FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1912347
·
Received November 9, 2010
Report
- Report Number
- 3007566237-2010-09118
- Event Type
- Injury
- Date Received
- November 9, 2010
- Date of Event
- August 20, 2010
- Report Date
- October 19, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) .
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WIRE WAS CRACKED AND THE BATTERIES WERE "DEAD." 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 | Required Intervention | IMPLANTED:| EXPLANTED:| LEAD: MODEL LEADMVD, LOT# UNKNOWN| IMPLANTED:| EXTENSION: MODEL EXTENSION MVD, LOT# UNKNOWN| EXPLANTED: |