FDA Adverse Event
Injury
Summary report: N
RELIA DR
MDR report key: 1925998
·
Received December 14, 2010
Report
- Report Number
- 6000094-2010-02305
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- October 6, 2010
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S097
- Removal / Correction Number
- ASKU
- 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND ON ANALYSIS OF DEVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT ONE DAY AFTER IMPLANT, NO PACING WAS OBSERVED ON THE ELECTROCARDIOGRAM AND THERE WAS NO DEVICE OUTPUT. THE DEVICE WAS EXPLANTED 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 |
|---|---|---|---|---|---|---|---|
| 1 | RELIA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC S.A. | REDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |