FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 1023429
·
Received April 2, 2008
Report
- Report Number
- 2182207-2008-01707
- Event Type
- Injury
- Date Received
- April 2, 2008
- Report Date
- November 11, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- UNK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING SUBMITTED FOLLOWING AN INTERNAL AUDIT.
Description of Event or Problem · 1
LITERATURE: PARR "DEEP BRAIN STIMULATION IN CHILDHOOD: AN EFFECTIVE TREATMENT FOR EARLY ONSET IDIOPATHIC GENERALIZED DYSTONIA" 2007/92/8/708-11. CASE 3 SUFFERED A CLINICAL DETERIORATION REQUIRING EMERGENCY BATTERY REPLACEMENT 2 YEARS POSTOPERATIVELY SECONDARY TO AN EXPIRED BATTERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | MHY | MEDTRONIC NEUROMODULATION | IPGNEURO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention | EXTENSION MODEL EXTENSION LOT # UNK IMPLANTED| LEAD MODEL LEADMVD LOT # UNK IMPLANTED| EXPLANTED| PROGRAMMER MODEL PROGRAMMER LOT # UNK IMPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL EXTENSION MVD LOT # UNK IMPLANTED| EXPLANTED| LEAD MODEL LEADMVD LOT # UNK IMPLANTED| EXPLANTED |