FDA Adverse Event
Injury
Summary report: N
ENDOTAK C
MDR report key: 1962293
·
Received January 18, 2011
Report
- Report Number
- 2124215-2011-00898
- Event Type
- Injury
- Date Received
- January 18, 2011
- Date of Event
- September 20, 2010
- Report Date
- October 2, 2010
- Manufacturer
- HISTORICAL CPI ST. PAUL
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS LEAD WAS SUCCESSFULLY REPLACED AND NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR DEFIBRILLATION LEAD WAS SURGICALLY ABANDONED AFTER A LEAD FRACTURE WAS SUSPECTED DUE TO PACING LEAD IMPEDANCE MEASUREMENTS OF GREATER THAN 3000 OHMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK C | IMPLANTABLE LEAD | NVY | HISTORICAL CPI ST. PAUL | 0074 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention | 1705| 1789| 0074| 1857| 1725| (B)(4)| MISMATCH| 0185| 1746 |