FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN LEAD
MDR report key: 3203126
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-02196
- Event Type
- Malfunction
- Date Received
- July 2, 2013
- Report Date
- June 4, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION REPORTED THE PHYSICIAN STATED THE COMMENTS WERE NOT LINKED TO SPECIFIC CASES OR PATIENTS AND THEY HAD NO FURTHER RECOLLECTION ON THIS EVENT.
Description of Event or Problem · 1
IT WAS REPORTED A POST-OPERATIVE MRI SHOWED THE PATIENT¿S LEAD MOVED. NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302708 | UNKNOWN LEAD | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_LEAD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |