FDA Adverse Event
Malfunction
Summary report: N
RESTORE SENSOR
MDR report key: 3192974
·
Received June 27, 2013
Report
- Report Number
- 3004209178-2013-10961
- Event Type
- Malfunction
- Date Received
- June 27, 2013
- Date of Event
- June 6, 2013
- Report Date
- June 6, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID NEU_UNKNOWN_LEAD; PRODUCT TYPE LEAD PRODUCT ID NEU_WRENCH_ACC; PRODUCT TYPE ACCESSORY. (B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS OF NEUROSTIMULATOR MODEL 37714 SERIAL # (B)(4), SHOWED NO ANOMALIES. ANALYSIS OF WRENCH ACCESSORY SHOWED NO ANOMALIES.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PERMANENT IMPLANT PROCEDURE, (THE TRIAL PROVIDED GOOD STIMULATION FOR THE PATIENT), THE PHYSICIAN WAS UNABLE TO INSERT THE LEAD TAIL ALL THE WAY INTO THE STIMULATOR. THE STIMULATOR WAS REPLACED AND THERE WERE NO FURTHER ISSUES. IT WAS FURTHER REPORTED THAT THE PATIENT WAS DOING "GREAT" AND HAD EFFECTIVE THERAPY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 292452 | RESTORE SENSOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37714 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR |