FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2092128
·
Received April 27, 2011
Report
- Report Number
- 3004209178-2011-03145
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- September 1, 2009
- Report Date
- April 8, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEFT SIDE DEEP BRAIN STIMULATOR WAS FOUND TO BE OFF AT A FOLLOW-UP VISIT ON (B)(6) 2009. THE PATIENT HAD "SET A METAL DETECTOR OFF". NO PATIENT ISSUES RELATED TO THIS EVENT WERE REPORTED FOR THE NEXT MONTH AND THE PATIENT FELT "GOOD".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | EXTENSION: MODEL 7482, LOT# NHU199165V| IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU199166V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V297034| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40: LOT# V297034| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LOT# NFW158783H| IMPLANTED: |