FDA Adverse Event
Injury
Summary report: N
DEEP BRAIN STIMULATION LEAD
MDR report key: 1025051
·
Received March 31, 2008
Report
- Report Number
- 2182207-2008-01706
- Event Type
- Injury
- Date Received
- March 31, 2008
- Report Date
- November 11, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- 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 HAS UNDERGONE OPERATIONS FOR LEAD DISPLACEMENT (CAUSED BY SLIDING DOWN STAIRS); SUBSEQUENTLY, THE UNIT REQUIRED REVISION DUE TO INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DEEP BRAIN STIMULATION LEAD | MHY | MEDTRONIC NEUROMODULATION | LEADMVD | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 8 YR | Required Intervention | IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTABLE PULSE GENERATOR MODEL IPGNEURO LOT#UNK| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL PROGRAMMER, LOT # UNK| EXPLANTED:| LEAD: MODEL LEAD MVD, LOT,# UNK| EXPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT # UNK| IMPLANTABLE PULSE GENERATOR MODEL IPGNEURO LOT#UNK| EXPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT # UNK |