FDA Adverse Event
Malfunction
Summary report: N
GEM VR
MDR report key: 1791845
·
Received August 10, 2010
Report
- Report Number
- 2647346-2010-00342
- Event Type
- Malfunction
- Date Received
- August 10, 2010
- Date of Event
- November 7, 2007
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P900061/S35
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) BATTERY DEPLETION-NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THE DEVICE WAS EXPLANTED AND REPLACED DUE TO OVERSENSING. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GEM VR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | 7227CX | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Required Intervention |