FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1942619
·
Received December 14, 2010
Report
- Report Number
- 3004209178-2010-10430
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- December 1, 2010
- Report Date
- December 2, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE DEEP BRAIN STIMULATOR SYSTEMS WERE REMOVED DUE TO INFECTION. REFERENCE MFG REPORT 3004209178-2010-10432. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 40 YR | Required Intervention | LEAD: MODEL 3389S-40, LOT # V439914| EXTENSION: MODEL 7482, LOT #: NHU212525V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT #: V397842| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LOT #: NFW163220H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT #: NHU212458V| EXPLANTED:| IMPLANTED: |