FDA Adverse Event
Malfunction
Summary report: N
ITREL 3
MDR report key: 3150706
·
Received June 6, 2013
Report
- Report Number
- 3007566237-2013-01882
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Report Date
- May 17, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT MENTIONED HIS PREVIOUS (THIRD) IMPLANTABLE NEUROSTIMULATOR (INS) DID NOT WORK. IT WAS ALSO STATED THE PATIENT FELT SHOCKING IN HIS LEGS WITH THIS INS AS WELL WITH THE ONE HE CURRENTLY HAD. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD PAIN AT THE IMPLANTABLE NEUROSTIMULATOR POCKET. IT WAS NOTED THAT THE PATIENT STATED THAT THEY ¿STILL FELT A STRONG STIMULATION SENSATION¿ TO THE ARMS. SEE MFR. REPORT 3004209178-2009-06268 FOR ADDITIONAL ISSUES THE PATIENT HAD WITH THE DEVICE. SEE MFR. REPORT 3004209178-2013-08745 FOR INFORMATION ABOUT THE PATIENT¿S CURRENT DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250875 | ITREL 3 | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7425 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00049 YR |