FDA Adverse Event
Malfunction
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1041241
·
Received May 9, 2008
Report
- Report Number
- 2182207-2008-02505
- Event Type
- Malfunction
- Date Received
- May 9, 2008
- Date of Event
- April 1, 2008
- Report Date
- April 9, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BUZZING SENSATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT IMPEDANCE READINGS GREATER THAN 2000 OHMS WERE OBTAINED ON ALL BUT ONE OF THE UNIPOLAR ELECTRODE PAIRS. TELEMETRY DATA WAS NOT PROVIDED. THE PATIENT HAD EXPERIENCED A BUZZING SENSATION IN HIS HEAD, THE DATE OF ONSET WAS UNKNOWN. NO OTHER SYMPTOMS OR PATIENT OUTCOME WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC NEUROMODULATION | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| PROGRAMMER MODEL UNK LOT# UNK| EXTENSION MODEL UNK LOT# UNK| EXTENSION MODEL UNK LOT# UNK| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL 7426 LOT# UNK| IMPLANTED:| EXPLANTED: |