FDA Adverse Event
Injury
Summary report: N
35CM BIPOLAR LEAD
MDR report key: 2011535
·
Received March 7, 2011
Report
- Report Number
- 2183787-2011-00019
- Event Type
- Injury
- Date Received
- March 7, 2011
- Report Date
- March 3, 2011
- 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
REVIEW OF MANUFACTURING RECORDS WAS PERFORMED. REVIEW AND CONFIRMATION OF MANUFACTURING RECORDS WAS PERFORMED. NO ANOMALIES WERE FOUND. DEVICE IS PART OF SEVERAL IMPLANTED COMPONENTS THAT COMPRISE A PACING SYSTEM. WE ARE UNABLE TO DETERMINE IF THE SUBJECT DEVICE CONTRIBUTED TO THE EVENT. A PORTION OF THE DEVICE WAS RETURNED TO (B)(4). HOWEVER, DURING DECONTAMINATION OF THE DEVICE, THE LEAD WAS MISPLACED AND IS UNABLE TO BE FOUND. THE MANUFACTURING RECORDS FOR THE DEVICE WERE REVIEWED AND THERE WERE NO ANOMALIES.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFO THAT THIS LEAD WAS EXPLANTED DUE TO PT INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 35CM BIPOLAR LEAD | BIPOLAR LEAD | DTB | GREATBATCH MEDICAL | 511211 | W39069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |