FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN DEEP BRAIN STIMULATOR
MDR report key: 2061837
·
Received April 4, 2011
Report
- Report Number
- 3007566237-2011-02552
- Event Type
- Malfunction
- Date Received
- April 4, 2011
- Date of Event
- March 17, 2011
- Report Date
- March 17, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
REC'D INFORMATION THE PT WAS IN THE INTENSIVE CARE UNIT AT THE HOSPITAL ON A VENTILATOR. THE PHYSICIAN REPORTS THE PT IS "JOLTING" AS IF BEING SHOCKED BY A DEFIBRILLATOR. THE MANUFACTURER'S REP WILL GO TO THE HOSPITAL AND TURN OFF THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF REC'D, A F/U REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN DEEP BRAIN STIMULATOR | MHY | MEDTRONIC NEUROMODULATION | IPGNEURO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |