FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2030874
·
Received March 4, 2011
Report
- Report Number
- 3007566237-2011-01644
- Event Type
- Malfunction
- Date Received
- March 4, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 17, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- 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
IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCKING OR JOLTING SENSATION, AND THE PATIENT'S DEVICE WAS SHOWING HIGH IMPEDANCE READINGS. THE HIGH IMPEDANCE READINGS WERE NOT UNEXPECTED AS THE PATIENT WAS ONLY TWO DAYS POST-IMPLANT. IT WAS REPORTED THE PATIENT EXPERIENCED A SHOCK WHEN THEY TOUCHED THE SKIN OVER THE DEVICE DURING A SHOWER. TROUBLESHOOTING WAS SUGGESTED, BUT NO PATIENT OUTCOME WAS REPORTED. PATIENT INFORMATION WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC NEUROMODULATION | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |