FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK DSP
MDR report key: 3213108
·
Received July 9, 2013
Report
- Report Number
- 2124215-2013-10255
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 6, 2013
- Report Date
- June 6, 2013
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVY
- PMA / PMN Number
- P910073
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ACCORDING TO AVAILABLE INFORMATION, THIS LEAD WILL NOT BE RETURNED FOR ANALYSIS. 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 RIGHT VENTRICULAR LEAD WAS SURGICALLY ABANDONED IN 2007. DURING A RECENT PROCEDURE, A DECISION WAS MADE TO EXPLANT THIS LEAD ALONG WITH THE DEVICE AND IMPLANTED RIGHT VENTRICULAR LEAD. DURING THE REMOVAL PROCESS, THIS LEAD BROKE APART. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 313241 | ENDOTAK DSP | IMPLANTABLE LEAD | NVY | GUIDANT PUERTO RICO BV | 0125 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | 1850| T177| 0158| 0125| F140| 0296| 1743| 1788 |