FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1051712
·
Received May 21, 2008
Report
- Report Number
- 6000153-2008-02677
- Event Type
- Injury
- Date Received
- May 21, 2008
- Date of Event
- March 2, 2006
- Report Date
- April 21, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT UNDERWENT A SURGICAL REPAIR OF HIS ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, THE PT SUFFERED SEVERE BRAIN DAMAGE AND/OR BURNS DUE TO THE USE OF ELECTROSURGICAL EQUIPMENT WHILE THE PT'S DEEP BRAIN STIMULATOR LEFT TURNED ON. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN/IF ADD'L INFO BECOMES AVAILABLE. REFERENCE MANUFACTURER REPORT #: 6000153200802678.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3387 | J0546774V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S | IMPLANTABLE NEURO STIMULATOR MODEL 7428| IMPLANTED:| IMPLANTED:| LEAD MODEL 3387 LOT# J0537802V| LOT# NFD102324H| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU103233V| EXPLANTED:| EXTENSION MODEL 7482 LOT# NHU095766V |