FDA Adverse Event
Malfunction
Summary report: N
2124215-2013-09415
MDR report key: 3212937
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-09415
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 11, 2013
- Report Date
- June 6, 2013
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE UPDATED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVE INFORMATION THAT SEVERAL DIFFERENT ISSUES OCCURRED WHEN IT COMES TO VARIOUS FLEXTEND AND FINLINE LEADS. THESE INCLUDE, DISLODGEMENT, INSULATION DEFECT, EXTENSION OF OPERATION AND X-RAY TIME. AT THIS TIME THE MODEL/SERIAL OF THE LEADS IS UNKNOWN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313063 | NVN | GUIDANT PUERTO RICO BV | BRADY LEAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |