FDA Adverse Event
Malfunction
Summary report: N
2124215-2013-08040
MDR report key: 3213569
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-08040
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- April 10, 2013
- Report Date
- April 10, 2013
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.
Description of Event or Problem · 1
BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TACHYCARDIA LEAD SUSTAINED A POSSIBLE FRACTURE AT THE DISTAL END OF THE PROXIMAL ELECTRODE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. ALL AVAILABLE INFORMATION INDICATES THAT NO INTERVENTION WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE STATUS OF THIS LEAD IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313714 | NVY | GUIDANT PUERTO RICO BV | TACHY LEAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR |