BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3122052 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-07966
    Event Type
    Malfunction
    Date Received
    May 21, 2013
    Report Date
    April 29, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V931596, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) DISCHARGED LAST (B)(6) 2013 AND HAD NOT BEEN WORKING. IT WAS NOTED A ¿DOCTOR ICON¿ WAS SHOWN ON THE PATIENT PROGRAMMER AND THE INS DIED ¿A LITTLE WHILE LATER.¿ IT WAS NOTED THE PATIENT SPOKE WITH A MANUFACTURING REPRESENTATIVE ABOUT 5-6 WEEKS PRIOR TO THIS REPORT. THE REPORTER STATED THE MANUFACTURING REPRESENTATIVE SAID THE INS SHOULD HAVE LASTED ABOUT 4-5 YEARS AND MUCH LONGER THAN THE PATIENT HAD USED THE INS. IT WAS NOTED THE PATIENT¿S HEALTHCARE PROFESSIONAL WAS AWARE OF THE SITUATION. IT WAS FURTHER NOTED THE IMPLANTABLE NEUROSTIMULATOR FAILED WITHIN A YEAR. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT REPORTED THAT THE MANUFACTURER¿S REPRESENTATIVE CONFIRMED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS DEAD WHEN INTERROGATED WITH A CLINICIAN PROGRAMMER (NO RESPONSE OR SIGNAL). IT WAS NOTED THAT IT WAS NOT NECESSARILY NORMAL INS BATTERY DEPLETION AS THE PATIENT¿S CAREGIVER (SON) REPORTED THAT THE AMPLITUDE WAS TURNED UP TO ¿7+¿. NO MALFUNCTIONS WERE SEEN OR THE CAUSE OF THE ISSUE DETERMINED. THE PATIENT WAS INSTRUCTED TO CONTACT THEIR PHYSICIAN FOR REPLACEMENT OF THE INS IF NECESSARY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S BATTERY WAS LOW. THIS WAS SHOWN ON THE PATIENT PROGRAMMER AND THE REPORTER THOUGHT THE DEVICE WAS ¿GOING TO LAST LONGER.¿ THE REPORTER STATED THAT HE THOUGHT THE DEVICE HAD HELPED ¿SOME BUT NOT AS MUCH AS THEY THOUGHT IT WAS GOING TO.¿ ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224360 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1