FDA Adverse Event
Injury
Summary report: N
54CM BIPOLAR LEAD
MDR report key: 2130473
·
Received June 13, 2011
Report
- Report Number
- 2183787-2011-00043
- Event Type
- Injury
- Date Received
- June 13, 2011
- Report Date
- June 13, 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.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM THAT EXPERIENCED A PT INFECTION. THERE WAS NO REPORT OF ADVERSE PT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 54CM BIPOLAR LEAD | BIPOLAR LEAD | DTB | GREATBATCH MEDICAL | 511212 | W34496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |