FDA Adverse Event
Injury
Summary report: N
ENDOTAK DSP
MDR report key: 2153407
·
Received July 7, 2011
Report
- Report Number
- 2124215-2011-07020
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- April 7, 2011
- Report Date
- April 7, 2011
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MOST RECENTLY, INFORMATION WAS RECEIVED INDICATING THAT THE RATE/SENSE PORTION OF THIS RV LEAD WAS SURGICALLY ABANDONED AND A NEW RATE/SENSE LEAD PLACED. THERE WAS NO ALLEGATION AGAINST THE ASSOCIATED ICD. NO FURTHER INFORMATION IS EXPECTED AT THIS TIME.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD DID EXHIBIT OUT-OF-RANGE PACE IMPEDANCE MEASUREMENT. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK DSP | IMPLANTABLE LEAD | NVY | GUIDANT PUERTO RICO BV | 0125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Required Intervention | 1790| 0125| H229| H179| 4525| 4470| 4518| 1740 |