FDA Adverse Event
Injury
Summary report: N
CAPSURE VDD 2
MDR report key: 3991004
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08368
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- April 23, 2014
- Report Date
- May 15, 2014
- Manufacturer
- MPRI
- Product Code
- DXY
- PMA / PMN Number
- P890003
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED A FAILURE TO PACE TWICE, AS WELL AS A SUDDEN DECREASE IN IMEPDANCES TO LOW LEVELS. THE LEAD WAS REPROGRAMMED, AND WAS LATER CAPPED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 471627 | CAPSURE VDD 2 | PULSE-GENERATOR, PACEMAKER, IMPLANTABLE | DXY | MPRI | 5038-58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Hospitalization| R | ADVDD01 IPG |