FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE NEUROSTIMULATOR
MDR report key: 2933870
·
Received January 29, 2013
Report
- Report Number
- 3007566237-2013-00313
- Event Type
- Injury
- Date Received
- January 29, 2013
- Report Date
- September 6, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A SUDDEN LOSS OF THERAPY, WHICH REVEALED A DISCONNECTION BETWEEN THE ADAPTOR AND THE EXTENSION. IT WAS NOTED THAT A SCREW APPEARED TO BE LOOSE. THE REPORTER STATED THAT THE PATIENT WAS RE-OPERATED ON, AND A NEW SCREW WAS USED TO RECONNECT THE ADAPTOR TO THE EXTENSION. THERE WERE NO PATIENT SYMPTOMS, AND THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 38558 | IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |