FDA Adverse Event
Malfunction
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1041268
·
Received May 9, 2008
Report
- Report Number
- 6000153-2008-02524
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Report Date
- April 11, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- 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
.
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A SHOCKING OR JOLTING SENSATION AFTER A FALL. X-RAY REVEALED THE LEAD HAD MIGRATED. THE REST OF THE DEVICE SYSTEM REMAINED INTACT. THE PT WILL BE REIMPLANTED BUT REVISION SURGERY HAD NOT YET BEEN SCHEDULED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN/IF ADDITIONAL INFO BECOMES AVAILABLE. REFER TO MEDWATCH REPORT #6000153-2008-02523.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3387 | J0235460V |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| LOT# NFD100434H| EXTENSION MODEL 7482 LOT# NHU057219V| IMPLANTED| IMPLANTED| LEAD MODEL 3387 LOT# J0424970V| IMPLANTED| IMPLANTED| IMPLANTABLE NEUROSTIMULATOR MODEL 7428| EXPLANTED| EXPLANTED| EXTENSION MODEL 7482 LOT# NHU052753V| EXPLANTED |