BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2964302 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02728
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    February 7, 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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V470212, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THE ¿INTERSTIM HAD WORKED OFF AND ON FOR THREE YEARS.¿ IT WAS NECESSARY TO REPLACE EVERYTHING BECAUSE THE ¿LEADS WERE GOING INTO SOMETHING.¿ IT WAS UNCLEAR WHAT THIS ¿SOMETHING¿ WAS. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD THEIR IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED DUE TO NORMAL BATTERY DEPLETION. IT WAS STATED THAT A LEAD FRACTURE OCCURRED DURING THE REMOVAL, WHICH RESULTED IN A PARTIAL PIECE OF THE LEAD BEING LEFT IN THE PATIENT. THE PATIENT RECOVERED WITHOUT SEQUELAE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT NUMEROUS ATTEMPTS WERE MADE TO REMOVE LEAD, AND ABOUT 5 CM OF THE LEAD TIP WERE NOT ABLE TO BE REMOVED DESPITE CUTTING DOWN IN THE SPINE. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68431 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Other| R