BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3013443 · Received March 20, 2013

    Report

    Report Number
    3007566237-2013-00845
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    March 4, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 388928, SERIAL # UNKNOWN, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF THERAPEUTIC EFFECT AND AN X-RAY SHOWED A TWISTED LEAD. IT WAS NOTED THAT REPROGRAMMING WAS DONE. THERE WERE NO PATIENT SYMPTOMS AND THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT WAS ¿DOING FINE.¿ IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT SAID THAT SHE DID NOT ROTATE THE IMPLANTABLE NEUROSTIMULATOR (INS). ABOUT A MONTH LATER IT WAS REPORTED THAT THE INS FELT TIGHT IN THE POCKET. THE PATIENT HAD NOT EXPERIENCED A SIGNIFICANT LOSS OF BODY WEIGHT. THE INS WAS SUTURED WITH TWO SUTURES AND THE PATIENT HAD NOT NOTICED A DIFFERENCE IN INS LOCATION OR ANGLE. THE PATIENT BEGAN NOTICING A CHANGE IN SYMPTOMS ON (B)(6) 2012 AND THIS WAS WHEN THE PATIENT BEGAN DOING WATER EXERCISES AGAIN, EIGHT WEEKS AFTER A REVISION. LATER THAT DAY IT WAS REPORTED THAT A REVISION WAS PLANNED BUT HAD NO DATE. THE PATIENT¿S STIMULATION WAS OFF AND AFTER THE LAST RE PROGRAMMING SHE FELT ¿IT¿ NEAR THE VAGINA. AN X-RAY WAS TAKEN AND THE LEAD ¿SEEMED TO LIE PERFECTLY, AT THE HEIGHT OF S3.¿ AS THE PATIENT HAD A SLOW LOSS OF EFFICACY AT THE END OF 2012 SHE RETURNED ¿SEVERAL TIMES¿ TO CHANGE THE STIMULATION AND AT THE MOST RECENT VISIT SHE DID NOT FEEL ANYTHING. IT IS UNCLEAR IF THIS WAS TRUE BECAUSE IT WAS ALSO REPORTED THAT SHE FELT IT NEAR THE VAGINA AFTER REPROGRAMMING. ABOUT TWO WEEKS LATER IT WAS REPORTED THAT THE REVISION WAS POSTPONED AND NO NEW DATE WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116233 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention