FDA Adverse Event
Malfunction
Summary report: N
35 CM BIPOLAR LEAD
MDR report key: 2192990
·
Received July 21, 2011
Report
- Report Number
- 2183787-2011-00060
- Event Type
- Malfunction
- Date Received
- July 21, 2011
- Report Date
- July 20, 2011
- Manufacturer
- GREATBATCH MEDICAL
- Product Code
- DTB
- PMA / PMN Number
- K925099
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULTS: REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. CONCLUSION: IT CANNOT BE DETERMINED WHETHER THE EVENT WAS RELATED TO DEVICE PERFORMANCE, OR PATIENT CONDITION SINCE THE DEVICE WAS NOT RETURNED TO (B)(4).
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD INDICATED THE LEAD DRAINED HER PACEMAKER'S BATTERY IN LESS THAN FOUR WEEKS AND BOTH THE DEVICE AND LEAD WERE REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 35 CM BIPOLAR LEAD | BIPOLAR LEAD | DTB | GREATBATCH MEDICAL | 511211 | W1609073 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |