BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4280606 · Received November 26, 2014

    Report

    Report Number
    3004209178-2014-22233
    Event Type
    Injury
    Date Received
    November 26, 2014
    Date of Event
    May 21, 2014
    Report Date
    June 5, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# V933650, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(6), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LOSS OF EFFECT FOLLOWING A HIP SURGERY ON (B)(6) 2014. THE THERAPY WAS TURNED OFF PRIOR TO SURGERY, BUT AFTER THE SURGERY, THE SYMPTOMS RETURNED EVEN WHEN THE DEVICE WAS TURNED ON. AS A RESULT OF THE LOSS OF THERAPY, THE PATIENT WANTED TO INCREASE STIMULATION ¿A COUPLE DAYS¿ PRIOR TO THE REPORT, BUT WAS NOT ABLE TO INCREASE IT. THE PATIENT PROGRAMMER SHOWED ¿CALL YOUR DOCTOR,¿ NOTING THERE WAS A POWER ON RESET (POR) CONDITION. THE MESSAGE WOULD DISAPPEAR, BUT THEN IT ¿KEPT COMING UP,¿ AND THE PATIENT WAS NOT ABLE TO INCREASE STIMULATION. FOLLOW UP IS BEING CONDUCTED TO DETERMINE PATIENT OUTCOME AND ACTIONS TAKEN TO RESOLVE THE ISSUE.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR WHO REPORTED THAT THE PATIENT'S LAST BATTERY WAS REPLACED DUE TO A FALL ON THEIR RIGHT HIP WHERE THE IMPLANT WAS "AND IT BLEW THE BATTERY OUT." THE INS WAS REPLACED AT THE TIME OF THIS REPORT AND NO ADDITIONAL PATIENT SYMPTOMS WERE REPORTED. THERE WERE NO FURTHER COMPLICATION REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED. HEALTH CARE PROFESSIONAL REPORTED THE FALL WAS DOCUMENTED (B)(6)2016. PATIENT DID NOT RETURN TO THEIR OFFICE AFTER THE FALL. THE CAUSE WAS UNKNOWN. NO FURTHER COMPLICATIONS ANTICIPATED/REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767267 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00066 YR Required Intervention