FDA Adverse Event
Injury
Summary report: N
ENDOTAK C
MDR report key: 2172969
·
Received July 23, 2011
Report
- Report Number
- 2124215-2011-10581
- Event Type
- Injury
- Date Received
- July 23, 2011
- Date of Event
- June 10, 2011
- Report Date
- June 13, 2011
- Manufacturer
- HISTORICAL CPI ST. PAUL
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE LEAD REMAINS IN SERVICE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE TO OUR COMPANY, THIS REPORT WILL BE UPDATED ACCORDINGLY.
Additional Manufacturer Narrative · 1
A COUPLE DAYS LATER THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD WAS EXHIBITING NOISE WHICH CAUSED AN INAPPROPRIATE SHOCK. LEAD INSULATION DAMAGE WAS SUSPECTED AND ALSO A POSSIBLE FRACTURE. THE DEVICE DEFIBRILLATION THERAPY WAS TURNED OFF PER THE PHYSICIAN'S REQUEST AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK C | IMPLANTABLE LEAD | NVY | HISTORICAL CPI ST. PAUL | 0064 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| L| R | H135| H175| MISMATCH| 6931| 6744| 6024| 4513| 1826| 0015| N119| 0064 |