FDA Adverse Event
Malfunction
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 2241042
·
Received August 17, 2011
Report
- Report Number
- 6000153-2011-06478
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- July 27, 2011
- Report Date
- July 27, 2011
- Manufacturer
- MPROC, VILLALBA
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE DOCTOR IMPLANTED THE LEAD AND INSERTED THE INNER CLIP OF THE STIMLOC CAP. HE CLOSED THE CLIP TO SECURE THE LEAD, REMOVED THE STYLET OF THE LEAD AND CONFIRMED THE POSITION. HE REMOVED THE MICRODRIVE AND BEFORE HE HAD THE CHANCE TO PLACE THE CAP ONTO THE STIMLOC THE JAWS OF THE INNER CLIP SPRUNG OPEN RESULTING IN LEAD MIGRATION OF APPROX 6 MM. THE SURGEON THEN REPOSITIONED THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MPROC, VILLALBA | 3387 | 0205131199 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | STIM ACCESSORY: MODEL M924456A, LOT# 082205911A |