FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1022592
·
Received April 1, 2008
Report
- Report Number
- 6000032-2008-01699
- Event Type
- Injury
- Date Received
- April 1, 2008
- Date of Event
- January 1, 2008
- Report Date
- March 3, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., MED-REL
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT BOTH PULSE GENERATORS WERE REMOVED FOR INFECTION; NO OTHER PT SYMPTOMS WERE PROVIDED. THE PROD WOULD BE RETURNED FOR ANALYSIS. ADD'L INFO HAS BEEN REQUESTED FROM THE PHYSICIAN. REFER TO MFR REPORT # 6000032-2008-01698.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO., MED-REL | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| IMPLANTED:| DEEP BRAIN STIMULATOR LEAD MODEL# UNK LOT# UNK| EXPLANTED:| PROGRAMMER MODEL UNK LOT # UNK| IMPLANTED:| EXPLANTED| IMPLANTED:| EXTENSION MODEL 7482 LOT# NHU033380V| EXPLANTED:| IMPLANTED:| DEEP BRAIN STIMULATOR LEAD MODEL UNK LOT# UNK| EXTENSION MODEL 7482 LOT# NHU033378V| IMPLANTED: |