FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 2810156
·
Received October 31, 2012
Report
- Report Number
- 6000094-2012-02329
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- August 9, 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 THERE WERE "PROBLEMS WITH PACING/SENSING" WHICH COULD BE DUE TO "DAMAGE/MALFUNCTION" OF THE CONNECTOR PART OF THE DEVICE. ALSO REPORTED WAS THE DEVICE WAS CLOSE TO THE ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS REPLACED. NO KNOWN PATIENT COMPLICATIONS WERE 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 | 9 YR | Hospitalization| R |