FDA Adverse Event
Injury
Summary report: N
MYOCARDIAL SUTURELESS PERMANENT PACING LEAD
MDR report key: 383731
·
Received March 22, 2002
Report
- Report Number
- 2182269-2002-00039
- Event Type
- Injury
- Date Received
- March 22, 2002
- Date of Event
- January 25, 1997
- Report Date
- March 21, 2002
- Manufacturer
- ST. JUDE MEDICAL, DAIG DIV., INC.
- Product Code
- DTB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- INVALID DATA
Narratives
Description of Event or Problem · 1
THIS EVENT WAS REPORTED TO SJM BY GUIDANT CORP FOLLOWING THE REMOVAL OF THE LEAD. THIS PERMANENT PACING LEAD WAS IMPLANTED IN 1988 AND IN 1997 IT WAS CAPPED AND REMOVED FROM SVC DUE TO INAPPROPRIATE SHOCKS FROM OVER SENSING. FOLLOWING THE DEATH OF THE PT IN 2001, THE LEAD WAS RETURNED TO GUIDANT FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MYOCARDIAL SUTURELESS PERMANENT PACING LEAD | PERMANENT PACING LEAD | DTB | ST. JUDE MEDICAL, DAIG DIV., INC. | 501170 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention | PERMANENT PACING LEAD # 0030. |