Table 2.

Durata leads

Case no.	Model	MDR event key	Lead age	Sign	Analysis
1	7120/65	2487350	48	Low impedance	Internal abrasion 23 cm from distal tip. RV conductor abraded: ‘This could cause the reported low impedance when in contact with the SVC shock coil’.
2	7120/65	2332798	38	Low impedance	Insulation abrasion near connector pin
3	7120/65	2409021	36	Insulation break near yolk	Analysis found insulation abrasion in unspecified location
4	7120/65	2463178	35	Intermittent loss of capture	Abrasion adjacent to proximal end of RV coil; friction with annuloplasty ring
5	7120/65	2409091	35	Low impedance	Can abrasion
					RV cables exposed
6	7122/65	2409053	33	Oversensing	Analysis found insulation abrasion in unspecified location
7	7170/65	2332939	33	Oversensing	Analysis found insulation abrasion in unspecified location
				Inappropriate shocks
8	7120/65	2084498	33	Low impedance	Can abrasion
					RV cables exposed; ETFE compromised
9	7121/65	2084194	31	Oversensing Inappropriate shocks	Can abrasion
					SVC cable abraded
10	7170/65	2084197	30	Oversensing Inappropriate shocks	Can abrasion
					Sensing cable exposed
11	7120/65	2333118	29	Inappropriate shocks	Analysis found insulation abrasion in unspecified location
				PG in back-up mode
12	7120/65	1954890	27	Inappropriate shocks	Analysis found insulation abrasion in unspecified location
13	7120/65	2015091	26	Oversensing	Can abrasion or friction with another lead
					Sensing coil flattened
14	7121/65	2487053	25	Unspecified	Abrasion 27 cm from connector
					Caused by friction with another device
15	7120/60	2014710	25	Unspecified	Abrasion 53 cm from connector exposing HV RV cables due to friction with another device
16	7170/65	2157205	24	Low impedance	Internal abrasion between 7 and 8 cm from the lead tip causing short circuit between the sensing and pacing conductor
17	7120/65	1955135	24	Abnormal sensing	Can abrasion affecting sensing cable insulation
18	7120/60	1679666	24	Inappropriate shocks	Abrasion at proximal end of RV shock coil due to friction with another device
19	7122/65	2487319	22	Unspecified	Can abrasion
					Coil melted
20	7120/65	1679680	22	Low impedance	Abrasion under the proximal end of the SVC coil. Intermittent contact between the RV shock cables and SVC coil
21	7122/65	1376803	22	Noise	Abrasion was observed on the lead at 14. 8–15. 2 cm from the connector pin
22	7122Q/65	2332898	20	Break	Abrasion probably due to clavicular crush
23	7122/65	2015063	20	Unspecified	Abrasion at 57. 7–58 cm at the proximal end of the RV shock coil due to friction with another device
24	7120/65	1895671	20	Inappropriate shocks	Failure due to sensing coil fracture. Incidental connector abrasion
25	7122Q/58	2242920	19	Unspecified	Can abrasion. RV cables exposed. Electrically normal
26	7122/65	1896015	19	Low impedance	Can abrasion. RV cable exposed.
27	7121/65	1679744	17	High impedance	Can abrasion
					Failure due to fracture.
28	7120/65	2332800	16	Unspecified	Abrasion in unspecified location
29	7121/65	1752115	15	Low impedance	Partial lead surface abrasion
30	7122/65	2409093	10	Low impedance	Abrasion was found between 38. 8 and 40. 9 cm from connector pin
31	7121/65	1830483	10	High impedance	Failure due to fracture.
				Oversensing	Incidental connector abrasion
32	7121Q/58	2084058	9	Noise	Abrasion at 44. 1–45 cm from connector pin due to friction with another device
				Low R-wave
33	7121Q/58	2015064	6	Break	Abrasion at 22 cm from the connector pin. The ETFE insulation of the svc cable and proximal cable were abraded due to clavicular crush
34	7122/60	1411082	6	Noise	Can abrasion. Cables exposed.
35	7122Q/65	2084562	5	Inappropriate shocks	Abrasion caused by clavicular crush
				Low impedance
36	7120Q/65	2242898	4	Unspecified	Surface abrasion 22 cm from connector
37	7120/60	1627605	3	Unspecified	Can abrasion exposing the RV and SVC cables

RV, right ventricle; SVC, superior vena cava; ETFE, ethylene-tetrafluoroethylene.