FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1031168
·
Received April 18, 2008
Report
- Report Number
- 6000153-2008-02085
- Event Type
- Injury
- Date Received
- April 18, 2008
- Report Date
- March 20, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAS EXPERIENCED SPEECH PROBLEMS RECENTLY. THE PT INQUIRED ABOUT COMPATIBILITY TESTING AND LABELING IN REGARDS TO THE EFFECTS OF METAL SCREWS AND TEETH. THE MANUFACTURER REVIEWED THE INFO WITH THE PT AND REDIRECTED THE PT TO CONTACT THE PHYSICIAN. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN/IF ADDITIONAL INFO BECOMES AVAILABLE. REFER TO MEDWATCH REPORT #6000153200802086. THE MANUFACTURER REVIEWED WITH THE PT THERE IS NO COMPATIBILITY TESTING AND/OR LABELING FOR THE PROCEDURE OR ACTIVITY NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3389 | J0349037V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED| IMPLANTED| EXPLANTED| EXTENSION MODEL 7489 LOT # NHU035281V| IMPLANTED| LOT # NFW119224H| IMPLANTABLE NEURO STIMULATOR MODEL 7426 |