FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 1172903
·
Received September 19, 2008
Report
- Report Number
- 3004209178-2008-05970
- Event Type
- Malfunction
- Date Received
- September 19, 2008
- Date of Event
- June 23, 2008
- Report Date
- August 22, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SHORT CIRCUIT.
Description of Event or Problem · 1
THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT, UNRELATED TO A KNOWN INCIDENT OR ACCIDENT. THE PATIENT WAS SEEN BY HIS HCP 3 DAYS LATER WHO DISCOVERED A SHORT ON ELECTRODES 2 AND 3 (IMPEDANCE NOT REPORTED). THE PATIENT STATUS WAS REPORTED AS 'UNKNOWN'; HE WAS NOT ABLE TO WITHSTAND SURGERY. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO. | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | LEAD: MODEL 3389| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL PROGRAMMER| EXPLANTED:| EXTENSION: MODEL 7482| EXPLANTED: |