FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1932037
·
Received November 30, 2010
Report
- Report Number
- 3004209178-2010-10051
- Event Type
- Malfunction
- Date Received
- November 30, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 18, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- 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
SEE MFR # 3004209178-2010-10048. THE IMPEDENCE MEASUREMENTS WERE GREATER THAN 2,000 OHMS WITH SOME OF THE UNIPOLAR PAIRS: 0&2, 0&3 AND 1&3. THE PT WAS NOT USING THOSE ELECTRODE COMBINATIONS WITHIN PROGRAMMING. THE PT'S RIGHT SIDE SYMPTOMS WERE GETTING WORSE. ADD'L INFO HAS BEEN REQUESTED.
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 | 66 YR | IMPLANTABLE NEURO STIMULATOR: MODEL 7426,| LOT # NFW146964H| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT # J0225534V| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT # NGK018163N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT # J0225368V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT # NGK018167N| EXPLANTED:| EXPLANTED: |