FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3951994
·
Received July 23, 2014
Report
- Report Number
- 3007566237-2014-02050
- Event Type
- Injury
- Date Received
- July 23, 2014
- Report Date
- July 16, 2014
- 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
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37651, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: RECHARGER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE RECHARGER MALFUNCTIONED. ADDITIONAL INFORMATION RECEIVED REPORTED THE RECHARGER COULD NOT RECHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT NO PATIENT SYMPTOMS WERE REPORTED. IT WAS FURTHER NOTED THAT NO TROUBLESHOOTING OR ACTIONS TAKEN WERE REPORTED. IT WAS NOTED THE PATIENT OUTCOME WAS NOT REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ON (B)(6) 2014, THE PATIENT HAD SURGERY TO TURN THE INS OVER. THE REPORTER STATED THE RECHARGER WAS NOT REPLACED AND WOULD NOT BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 431569 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |