SOLETRA
Report
- Report Number
- 3004209178-2012-04591
- Event Type
- Malfunction
- Date Received
- June 18, 2012
- Report Date
- May 22, 2012
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# V230720, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3389S-40, LOT# V234704, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7426, SERIAL #(B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR.(B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED, THE PATIENT HAD ISSUES WHERE THE IMPLANTABLE NEUROSTIMULATOR (INS) CUT ON AND OFF. THE REPORTER STATED THIS OCCURRED WHEN THE PATIENT GOES THROUGH METAL DETECTORS AT THE STORE OR AIRPORT. THE REPORTER FURTHER STATED THIS OCCURRED PERIODICALLY.
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) TURNED OFF AFTER WALKING THROUGH STORE SECURITY AND AFTER USING A DRILL WHICH CAUSED HIM TO SWEAT PROFUSELY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MDT PUERTO RICO OPERATIONS CO | 7426 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |