FDA Adverse Event
Injury
Summary report: N
ENDOTAK DSP
MDR report key: 3963614
·
Received July 29, 2014
Report
- Report Number
- 2124215-2014-14612
- Event Type
- Injury
- Date Received
- July 29, 2014
- Date of Event
- June 6, 2014
- Report Date
- June 13, 2014
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE POST MARKET QUALITY ASSURANCE LABORATORY WILL ANALYZE THE LEAD WHEN IT IS RETURNED. THIS REPORT WILL BE UPDATED ONCE ADDITIONAL INFORMATION IS AVAILABLE.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OCCASIONAL NOISE AND OVERSENSING RESULTING IN THE INAPPROPRIATE STORAGE OF NON-SUSTAINED VENTRICULAR EVENTS. AN INSULATION ISSUE WAS SUSPECTED. THE TACHY THERAPIES WERE TURNED OFF AND THE PATIENT WAS FITTED WITH A LIFE VEST UNTIL A NEW RV LEAD COULD BE PLACED. SUBSEQUENTLY, THE LEAD WAS EXPLANTED DUE TO FRACTURE. A NEW RV LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 442504 | ENDOTAK DSP | IMPLANTABLE LEAD | LWS | CPI - DEL CARIBE | 0125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| L| R | 4440| 1821| MISMATCH| 1861| 0125 |