FDA Adverse Event
Injury
Summary report: N
ITREL 3
MDR report key: 3022826
·
Received March 27, 2013
Report
- Report Number
- 3007566237-2013-00898
- Event Type
- Injury
- Date Received
- March 27, 2013
- Report Date
- March 13, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS INITIALLY REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD REACHED END-OF-SERVICE (EOS). FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE EOS ON THE INS WAS CONSIDERED NORMAL BATTERY DEPLETION. IT WAS NOTED THAT THE PATIENT EXPERIENCED A GRADUAL LOSS OF STIMULATION AND A RETURN OF THEIR PAIN. IN ADDITION, IT WAS REPORTED THAT THE PATIENT HAD TWO SURGERIES BUT FINALLY HAD STIMULATION THAT PROVIDED PAIN RELIEF. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT. SEE MANUFACTURER'S REPORT #S 9614453-2012-00140 AND 3007566237-2012-02153 FOR OTHER DEVICE ISSUES WITH THIS PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125933 | ITREL 3 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | 7425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |