FDA Adverse Event
Injury
Summary report: N
ENDOTAK RELIANCE
MDR report key: 3210379
·
Received July 8, 2013
Report
- Report Number
- 2124215-2013-08101
- Event Type
- Injury
- Date Received
- July 8, 2013
- Date of Event
- April 18, 2013
- Report Date
- April 18, 2013
- Manufacturer
- GUIDANT PUERTO RICO BV
- Product Code
- NVY
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS NOT EXPECTED TO BE RETURNED. 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 AT A ROUTINE FOLLOW-UP, THIS RIGHT VENTRICULAR (RV) LEAD SHOWED DOUBLE COUNTING OF P- AND R-WAVES. THIS RESULTED IN THE PATIENT RECEIVING AN INAPPROPRIATE SHOCK ON THREE SEPARATE OCCASIONS. AN X-RAY WAS PERFORMED, WHICH CONFIRMED THE DISTAL COIL OF THE RV LEAD WAS BETWEEN THE ATRIUM AND THE VENTRICLE. A REVISION WAS ATTEMPTED, BUT THE LEAD COULD NOT BE REPOSITIONED. THE LEAD WAS EXTRACTED AND A NEW LEAD WAS IMPLANTED SUCCESSFULLY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309830 | ENDOTAK RELIANCE | NVY | GUIDANT PUERTO RICO BV | 0292 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Hospitalization| L| R | 030-247| 1283| 0950| 4285| 0465| 1010 |