FDA Adverse Event
Death
Summary report: N
DEEP BRAIN STIMULATOR LEAD
MDR report key: 1000154
·
Received February 15, 2008
Report
- Report Number
- 2182207-2008-00731
- Event Type
- Death
- Date Received
- February 15, 2008
- Report Date
- January 18, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
DEATH WAS NOT REPORTED AS DEVICE RELATED.
Description of Event or Problem · 1
JOURNAL REFERENCE: MCCLELLAND ET AL. "RELATIONSHIP OF CLINICAL EFFICACY TO POSTMORTEM-DETERMINED ANATOMIC SUBTHALAMIC STIMULATION IN PARKINSON SYNDROME." CLIN NEUROPATHOL 2007; 26(6); 267-275. THIS ARTICLE DESCRIBES A MALE WITH PARKINSON'S DISEASE WHO WAS PROSPECTIVELY FOLLOWED IN A LONG-TERM CLINICAL PROTOCOL UNTIL HIS DEATH, 40 MOS AFTER ELECTRODE PLACEMENT. AFTER NON-DEVICE RELATED DEATH, THE AUTOPSY CONFIRMED THAT ONE LEAD HAD LIKELY MIGRATED IMMEDIATELY AFTER INSERTION AND THEREFORE DID NOT PROVIDE COMPLETE BENEFIT TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATOR LEAD | MHY | MEDTRONIC NEUROMODULATION | 3389 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Death | IMPLANTABLE EXTENSION MODEL 7495| IMPLANTABLE NEURO STIMULATOR MODEL 7426 |