BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3940464 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13138
    Event Type
    Malfunction
    Date Received
    July 17, 2014
    Report Date
    February 1, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT # V509981, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT # V509981, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL IN (B)(6) 2013 AND ¿ALL OF A SUDDEN¿ THE IMPLANTABLE NEUROSTIMULATOR (INS) STOPPED BEING EFFECTIVE. IT WAS STATED THAT THE MANUFACTURER REPRESENTATIVE REPROGRAMMED THE INS FOR HER IN (B)(6) 2014 AND WAS ABLE TO GET THE INS TO BE ¿SOMEWHAT EFFECTIVE.¿ THE MANUFACTURER REPRESENTATIVE REPORTEDLY TOLD THE PATIENT THAT WHEN SHE FELL, THE LEAD PULLED AWAY FROM THE NERVE. IT WAS THEN STATED THAT THE LEAD DID NOT PULL AWAY ENTIRELY, BUT ¿SLIPPED.¿ IT WAS ALSO STATED THAT THE PATIENT¿S BACK HAD BEEN HURTING SINCE (B)(6) 2013 AND IT WAS DESCRIBED AS A ¿DULL ACHE/SORE BACK.¿ IT WAS MENTIONED THAT THE PATIENT¿S HEALTHCARE PROVIDER (HCP) DID NOT THINK THE BACK PAIN WAS RELATED TO THE DEVICE. IT WAS ALSO REPORTED THAT ON (B)(6) 2014, THE PATIENT HAD A BACK SPASM FOR THE FIRST TIME. IT WAS STATED TO HAVE COME ON SUDDENLY AND IT WAS SO SEVERE THAT THE PATIENT COULD NOT TELL IF IT WAS HER BLADDER OR BACK. THE PATIENT USED HEAT TO HELP CALM THE SPASM TO A DULL ACHE. THE PATIENT HAD ANOTHER SPASM ON (B)(6) 2014 AND USED HEAT TO CALM IT AGAIN. IT WAS NOTED THAT THE SPASM WAS BETWEEN THE INS AND THE LEAD. THE PATIENT THOUGHT THE SPASMS TO BE DEVICE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419372 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR