FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 2708021
·
Received August 21, 2012
Report
- Report Number
- 3004209178-2012-07156
- Event Type
- Injury
- Date Received
- August 21, 2012
- Report Date
- July 23, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). LEAD MODEL 3387S-40, LOT# V012374, IMPLANTED: 2007 (B)(6), EXPLANTED: UNK; EXTENSION, MODEL 748251, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: UNK; PROGRAMMER, MODEL 7438, SERIAL# (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INFECTION WAS NOT RELATED TO THE PATIENT'S DBS THERAPY. A CULTURE WAS TAKEN, BUT THE RESULTS WERE NOT KNOWN. IT WAS NOT KNOWN IF ANY INTERVENTIONS WERE PLANNED REGARDING THE DBS DEVICES. THE PATIENT OUTCOME WAS UNKNOWN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS SEPTIC AND HAD A MAJOR INFECTION. THE HCP WAS EXPLANTING THE PATIENT'S ICD. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE ALSO MFR. REP. # 3004209178-2012-07155..
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |