FDA Adverse Event
Malfunction
Summary report: N
35 CM BIPOLAR LEAD
MDR report key: 1931962
·
Received November 30, 2010
Report
- Report Number
- 2183787-2010-00066
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Report Date
- November 30, 2010
- Manufacturer
- GREATBATCH MEDICAL
- Product Code
- DTB
- PMA / PMN Number
- K925099
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
RESULT: REVIEW AND CONFIRMATION OF MFG RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. CONCLUSION: IT CANNOT BE DETERMINED WHETHER THE EVENT WAS RELATED TO DEVICE PERFORMANCE, OR PT CONDITION.
Description of Event or Problem · 1
GUIDANT RECEIVED INFO THAT THIS VENTRICULAR IMPLANTABLE LEAD, WHICH HAD BEEN IMPLANTED FOR LESS THAN A YEAR, WAS EXPLANTED AND REPLACED DUE TO HIGH THRESHOLDS. ANOTHER LEAD WAS IMPLANTED. HOWEVER, IT WAS TAKEN OUT OF SERVICE ON THE DAY OF IMPLANT DUE TO HIGH THRESHOLDS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 35 CM BIPOLAR LEAD | BIPOLAR LEAD | DTB | GREATBATCH MEDICAL | 511211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |