FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEUROSTIMULATOR
MDR report key: 2875107
·
Received December 17, 2012
Report
- Report Number
- 3007566237-2012-03031
- Event Type
- Injury
- Date Received
- December 17, 2012
- Report Date
- November 20, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-28, SERIAL# UNKNOWN, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. THE INITIAL REPORTER'S PHONE NUMBER WAS LISTED AS: (B)(6). (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO A BREAK OR FRACTURE. THE PATIENT ALSO HAD A LOSS OF STIMULATION AND THERAPEUTIC EFFECT. THERE WERE NO PATIENT SYMPTOMS OR INJURIES. 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 |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN NEUROSTIMULATOR | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |