FDA Adverse Event
Injury
Summary report: N
CONSULTA CRT-D
MDR report key: 2810481
·
Received October 31, 2012
Report
- Report Number
- 6000094-2012-02366
- Event Type
- Injury
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NIK
- Removal / Correction Number
- Z-0111-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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. THIS MODEL NUMBER IS NOT APPROVED FOR DISTRIBUTION IN THE UNITED STATES, HOWEVER, IT IS SAME/SIMILAR TO A DEVICE MARKETED IN THE U.S.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE INDICATED RECOMMENDED REPLACEMENT TIME (RRT) AND THE DEVICE HAD UNEXPECTED LONGEVITY. THE DEVICE WILL BE 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 | CONSULTA CRT-D | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC S.A. | D234TRK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |