FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 2143023
·
Received June 23, 2011
Report
- Report Number
- 6000153-2011-04695
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- May 25, 2011
- Report Date
- May 25, 2011
- Manufacturer
- MPROC, VILLALBA
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT DID NOT RECEIVE ANY BENEFIT FROM THE LEAD IN THE RIGHT SIDE OF THE BRAIN. AN IMPEDANCE TEST WAS PERFORMED AND VALUES WERE GREATER THAN 10,000 OHMS FOR EACH ELECTRODE COMBINATION OF THE LEAD. THE TRIALING CABLE WAS EXCHANGED AND AN IMPEDANCE CHECK REVEALED OUT OF RANGE VALUES FOR ONLY ELECTRODE 0. A NEW LEAD WAS IMPLANTED AND, WHEN TESTED, ALL IMPEDANCE VALUES WERE WITHIN NORMAL LIMITS. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MPROC, VILLALBA | 3389 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | MODEL UNK, SERIAL# UNK| IMPLANTED:| STIM ACCESSORY: MODEL 3555-31, LOT# N287246| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEUROSTIMULATOR: |