FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE NEUROSTIMULATOR
MDR report key: 2911581
·
Received January 11, 2013
Report
- Report Number
- 3007566237-2013-00126
- Event Type
- Injury
- Date Received
- January 11, 2013
- Report Date
- December 20, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AN INTERVIEW, A NEUROLOGIST MENTIONED THEY HAVE HAD "SEVERAL PATIENTS" WHO HAD TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) "REPLACED SOONER THAN EXPECTED." IT WAS INDICATED THE BATTERY LIFE WAS SHORT. IT WAS STATED BY THE NEUROLOGIST THAT "CONSTANT CURRENT MODE ON THE INS USED THE BATTERY LIKE HELL." IN ADDITION, THE NEUROLOGIST TOLD HIS PATIENTS, "ACCORDING TO THE MANUFACTURER, THE DEVICE CAN LAST UP TO FIVE YEARS." THE NEUROLOGIST CONTINUED STATING THAT "WITHIN LESS THAN TWO YEARS, A YEAR AND A HALF, THEY BURN OUT AND REQUIRE REPLACEMENT." NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19021 | IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |