FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 5648581
·
Received May 11, 2016
Report
- Report Number
- 3007566237-2016-01945
- Event Type
- Injury
- Date Received
- May 11, 2016
- Date of Event
- December 9, 2005
- Report Date
- May 11, 2016
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MRU
- PMA / PMN Number
- H020007
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID NEU_INS_STIMULATOR, LOT # UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
DIAMOND, A., SHAHED, J., AZHER, S., DAT-VUONG, K., JANKOVIC, J. GLOBUS PALLIDUS DEEP BRAIN STIMULATION IN DYSTONIA. MOVEMENT DISORDERS. 2006. 21: 5 (692-695). SUMMARY: GLOBUS PALLIDUS DEEP BRAIN STIMULATION (GPI-DBS) IS A USEFUL ALTERNATIVE IN THE TREATMENT OF DYSTONIA. REPORTED EVENT: 1 PATIENT WITH GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA DEVELOPED A SKIN INFECTION AND SKIN EROSION REQUIRING SURGICAL DEBRIDEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 302563 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) | MRU | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |