FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2153439
·
Received June 21, 2011
Report
- Report Number
- 9614453-2011-04645
- Event Type
- Malfunction
- Date Received
- June 21, 2011
- Date of Event
- December 15, 2009
- Report Date
- May 25, 2011
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTED NEUROSTIMULATOR SHUT OFF SPONTANEOUSLY. THE DEVICE SHUT DOWN WHILE THE PATIENT WAS SITTING, AND WHEN THE PATIENT STOOD UP, HE FELT A LACK OF THERAPEUTIC EFFECT. THE PHYSICIAN INTERROGATED THE DEVICE AND CONFIRMED THE DEVICE HAD TURNED OFF THREE TIMES. NO KNOWN ELECTROMAGNETIC INTERFERENCE WAS REPORTED. THE DEVICE INDICATED THAT ALL PARAMETERS (FOR VOLTAGE AND IMPEDANCE) WERE WITHIN NORMAL LIMITS. THE PHYSICIAN GAVE THE PATIENT A MAGNET TO USE TO SWITCH THE DEVICE ON HIMSELF. THE PATIENT'S STATUS WAS UNDETERMINED AT THE TIME OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC EUROPE SARL | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |