SOLETRA
Report
- Report Number
- 3004209178-2012-11089
- Event Type
- Injury
- Date Received
- December 3, 2012
- Report Date
- November 7, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT ID 7495LZ25, SERIAL # (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE EXTENSION; PRODUCT ID 3587A, LOT # L81374, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD;, PRODUCT ID 3587A, LOT # L84136, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD.
(B)(4).
IT WAS REPORTED THE SYSTEMS HAD NOT WORKED FOR A LONG TIME. IT WAS UNCLEAR WHICH SYSTEM THE HEALTH CARE PROFESSIONAL WAS REFERRING TO AS THE PATIENT HAD BOTH SCS AND DBS SYSTEMS. IT WAS ALSO NOTED THE HEALTH CARE PROFESSIONAL WANTED TO KNOW IN WHAT CONDITION THE PATIENT COULD HAVE AN MRI. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER # 3004209178-2012-11080 FOR REPORT ON SCS DEVICE IN PATIENT.
FOLLOW UP REPORTED THE HEALTH CARE PROFESSIONAL HAD NOT EXPLANTED ANYTHING AND THE LAST TIME THE PATIENT HAD BEEN SEEN WAS (B)(6) 2011. THE PATIENT HAD BEEN HAVING HIGH IMPEDANCES BUT THEY HAD NEVER DETERMINED WHY. IT WAS NOTED THE SAME THING HAPPENED IN 2010 WITH HIGH IMPEDANCES. IT WAS NOTED THE PATIENT NEVER WENT BACK TO THE HEALTH CARE PROFESSIONAL IN EITHER INSTANCE. THE HEALTH CARE PROVIDER HAD NO FURTHER INFORMATION ON THE PATIENT. REFER TO MANUFACTURER # 3004209178-2012-11080 FOR REPORT ON SPINAL CORD STIMULATOR DEVICE.
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 |