BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 2881932 · Received December 20, 2012

    Report

    Report Number
    3007566237-2012-03080
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Report Date
    November 29, 2012
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL DEVICE: PRODUCT ID: 37081-40, SERIAL#: UNKNOWN, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD NOT FELT ANY STIMULATION AFTER HE HAD DONE STRETCHING EXERCISES. AFTER IMPEDANCES WERE CHECKED, THREE CONTACTS HAD VALUES >10000 OHMS. PATIENT STATUS AT TIME OF THIS REPORT WAS ALIVE WITH NO INJURY/NO ADVERSE EVENT. THE PHYSICIAN ASKED FOR A RADIOLOGICAL EXAMINATION. LESS THAN 50% THERAPY RELIEF WERE NOTED AS PATIENT SYMPTOMS/COMPLICATIONS. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THERE WAS NO TROUBLESHOOTING PERFORMED AND THAT THERE WAS NO FURTHER INFORMATION AVAILABLE REGARDING THE PATIENT'S STATUS/OUTCOME. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1