FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2193294
·
Received July 13, 2011
Report
- Report Number
- 3004209178-2011-05381
- Event Type
- Malfunction
- Date Received
- July 13, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 20, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- 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
IT WAS REPORTED THAT IMPEDANCE READINGS ON THE PT'S DEVICE WERE GREATER THAN 2,000 OHMS ON ALL OF THE UNIPOLAR PAIRS. THE PT'S THERAPY WAS OK. THE PT WAS PROGRAMMED USING ELECTRODES 0 AND 3. IT WAS LATER REPORTED THAT THE PT'S PHYSICIAN NOTED SIMILAR IMPEDANCE READINGS, BUT THE PT CONTINUED TO RECEIVE EFFECTIVE RESOLUTION OF SYMPTOMS WITH A GOOD CLINICAL OUTCOME. THERE WAS NO FURTHER TROUBLESHOOTING OR INTERVENTION PERFORMED. THE PT WAS TO SEE THE PHYSICIAN FOR A F/U APPOINTMENT IN (B)(6). A F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR | IMPLANTED:| LEAD: MODEL 3387S, LOT #V018999| EXPLANTED:| EXTENSION: MODEL 7482, LOT #NHU145283V| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7438, LOT #NHL020226P |