FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3984089
·
Received August 6, 2014
Report
- Report Number
- 3007566237-2014-02200
- Event Type
- Injury
- Date Received
- August 6, 2014
- Report Date
- July 18, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 64002, SERIAL# UNKNOWN, PRODUCT TYPE: ADAPTER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THERE WAS DECUBITUS OF THE SYSTEM AND THERE WAS AN ADAPTOR ISSUE. THE REPORTER STATED THAT DECUBITUS HAD BEEN ASSOCIATED TO FORM ON ADAPTORS. THE REPORTER FURTHER STATED THAT A POCKET REVISION HAD BEEN DONE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 459676 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |