BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3142426 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08531
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 14, 2013
    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
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# V880220, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3093-28, LOT# V880220, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT REPORTEDLY NOTICED A RETURN OF SYMPTOMS THE WEEK PRIOR TO THE REPORT. THE REPORTER INDICATED THAT THE PATIENT HAD BEEN ¿PEEING IN INTERVALS, NOT IN ONE FULL STREAM¿. IT WAS NOTED THAT THE PATIENT NEEDED TO ¿PUSH ON HER ABDOMEN¿ IN ORDER TO EMPTY HER BLADDER. THE REPORTER STATED THAT ¿IT SEEMED TO HAVE BEEN GOING BACK TO WHAT IT WAS BEFORE THE IMPLANT¿. THE PATIENT TRIED TO INCREASE STIMULATION UP TO 8.5V, AS FAR AS IT WOULD GO ON ONE PROGRAM, AND IT DID NOT RELIEVE THE PATIENT OF HER SYMPTOMS. ANOTHER PROGRAM DID NOT RELIEVE THE PATIENT OF HER SYMPTOMS EITHER. THE REPORTER NOTED THAT THE PATIENT HAD NOT SEEN HER HEALTHCARE PROVIDER (HCP) SINCE SHE WAS IMPLANTED. IT WAS INDICATED THAT THE PATIENT HAD A NUCLEAR RADIATION CHEMICAL STRESS TEST AS WELL AS AN XRAY OF THE HEART DONE ON (B)(6) 2013. IT WAS LATER REPORTED THAT THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT WITH HER HCP ON (B)(6) 2013. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED WHICH REPORTED THAT THE PATIENT FELL AND BROKE THE ¿MAIN¿ LEAD TO HER IMPLANTABLE NEUROSTIMULATOR (INS). HOWEVER, THE PATIENT¿S HEALTHCARE PROVIDER REPROGRAMMED THE INS AT HER (B)(6) APPOINTMENT PREVIOUSLY NOTED. THE PATIENT'S CONCERNS WERE SUBSEQUENTLY RESOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FELL THE YEAR PRIOR TO THE REPORT AND ¿BROKE SOME LEADS.¿ IT WAS NOTED THAT THE PATIENT WENT IN FOR REPROGRAMMING AND SINCE THEN IT WAS NOT WORKING ¿AS WELL AS IT SHOULD.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243328 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1