FDA Adverse Event
Injury
Summary report: N
SWEET TIP
MDR report key: 2778276
·
Received October 9, 2012
Report
- Report Number
- 2124215-2012-12341
- Event Type
- Injury
- Date Received
- October 9, 2012
- Date of Event
- August 14, 2012
- Report Date
- August 14, 2012
- Manufacturer
- CPI - DEL CARIBE
- Product Code
- NVN
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AT THIS TIME, THIS LEAD HAS NOT BEEN RETURNED. IF ADDITIONAL INFORMATION IS RECEIVED, THIS REPORT WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS FOUND TO BE CRIMPED. THE LEAD WAS SURGICALLY ABANDONED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWEET TIP | IMPLANTABLE LEAD | NVN | CPI - DEL CARIBE | 4244 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Hospitalization| L| R | 1273| 4244| 4035 |