FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 3211188
·
Received July 8, 2013
Report
- Report Number
- 3004209178-2013-11453
- Event Type
- Injury
- Date Received
- July 8, 2013
- Report Date
- June 12, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7426, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# V296975. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V296975. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V196743, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 7438, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009. PRODUCT TYPE: EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD 2 DEEP BRAIN STIMULATORS (DBS) SETS REMOVED DUE TO INFECTION. REFER TO MANUFACTURING REPORT # 3004209178-2013-11452.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 310455 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |