FDA Adverse Event
Injury
Summary report: N
INSYNC MAXIMO
MDR report key: 1926166
·
Received December 14, 2010
Report
- Report Number
- 6000094-2010-02310
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- October 4, 2010
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S18
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- 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 RECEIVED INAPPROPRIATE SHOCKS AND THE DEVICE VOLTAGE HAD DECREASED. THE DEVICE WAS REPLACED. NO FURTHER 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 | 43 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| 6931 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD |