FDA Adverse Event
Injury
Summary report: N
UNKNOWN DEEP BRAIN STIMULATOR
MDR report key: 1910483
·
Received November 18, 2010
Report
- Report Number
- 3007566237-2010-09759
- Event Type
- Injury
- Date Received
- November 18, 2010
- Date of Event
- September 1, 2010
- Report Date
- November 10, 2010
- 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
THE PT HAD DBS DEVICE IMPLANTED FIVE YEARS AGO. IN (B)(6), THE DOCTOR FOUND THE LEAD EXPOSED. THE LEAD WAS CHANGED ON (B)(6). THE PT IS WELL NOW.
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 | Required Intervention | IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# UNKNOWN |