FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEUROMODULATION DEVICE
MDR report key: 3083301
·
Received April 29, 2013
Report
- Report Number
- 3007566237-2013-01469
- Event Type
- Injury
- Date Received
- April 29, 2013
- Date of Event
- April 17, 2013
- Report Date
- April 17, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- 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). (B)(6).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD AN EROSION AT THE POCKET AFTER IMPLANTING AN ADAPTER. IT WAS NOTED THAT "FURTHER SURGERY WAS REQUIRED," AND THE SURGEON PLANNED TO REVISE THE POSITION OF THE IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184565 | UNKNOWN NEUROMODULATION DEVICE | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |