FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN LEAD
MDR report key: 3203495
·
Received July 2, 2013
Report
- Report Number
- 3007566237-2013-02193
- 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 THE ¿OLD SYSTEM¿ WOULD PUSH THE LEAD DEEPER. IT WAS ALSO STATED THE HEALTHCARE PROVIDER LIKED THE LOWER PROFILE COMPARED TO THE OLD DEVICE AND ¿LOCKING ELECTRODE IN PLACE.¿ 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 |
|---|---|---|---|---|---|---|---|
| 302804 | UNKNOWN LEAD | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_LEAD | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |