FDA Adverse Event
Malfunction
Summary report: N
INSYNC MAXIMO
MDR report key: 2201361
·
Received August 11, 2011
Report
- Report Number
- 6000094-2011-01321
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S18
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- 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 PATIENT WAS EXPERIENCING A BUZZING SENSATION WITH ASSOCIATED HEATING OF THE DEVICE SITE ON SOME MORNINGS. THE DEVICE AND LEADS CHECKED OUT OKAY. THE DEVICE IS STILL IN USE. PATIENT WILL FOLLOW UP IN (B)(6). NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC MAXIMO | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC S.A. | 7304 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |