FDA Adverse Event
Malfunction
Summary report: N
CAPSURE Z
MDR report key: 6161093
·
Received December 9, 2016
Report
- Report Number
- 2649622-2016-14424
- Event Type
- Malfunction
- Date Received
- December 9, 2016
- Date of Event
- September 6, 2016
- Report Date
- September 6, 2016
- Manufacturer
- MPRI
- Product Code
- DTB
- PMA / PMN Number
- P850089
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: ADDR01 IPG IMPLANTED: (B)(6) 2015.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH COMPLAINTS OF LIGHTHEADEDNESS AND DIZZINESS. THE ELECTROGRAM SHOWED POSSIBLE LOSS OF CAPTURE ON THE RIGHT VENTRICULAR (RV) LEAD. THE LEAD IS STILL IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 808372 | CAPSURE Z | ELECTRODE, PACEMAKER, PERMANENT | DTB | MPRI | 503452 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | 553445 LEAD |