FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 2812881
·
Received October 31, 2012
Report
- Report Number
- 6000094-2012-02490
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- Z-2120-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE HAD REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). AFTER REVIEW OF DATA, UNCLEARABLE ERI LOCKUP WAS SUSPECTED. THE PACEMAKER WAS CHECKED WITH AN UPDATED PROGRAMMER, AND THE LOCKUP WAS RELEASED. NORMAL FUNCTION WAS CONFIRMED. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC S.A. | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |