BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3082441 · Received April 29, 2013

    Report

    Report Number
    3004209178-2013-07001
    Event Type
    Injury
    Date Received
    April 29, 2013
    Report Date
    April 9, 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
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V278189, IMPLANTED: (B)(6) 2009. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V278189, IMPLANTED: 2009-(B)(6), EXPLANTED: 2013-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS BETWEEN 15% AND 30% OF THE INS BATTERY LEFT. THERE WERE 2 ELECTRODES ON THE LEAD THAT WERE NOT WORKING AND THE PATIENT HAD LOST WEIGHT. DUE TO THESE THREE FACTORS THE DOCTOR WAS CONSIDERING REPLACING THE WHOLE SYSTEM AND MENTIONED MOVING IT TO THE OTHER SIDE. THE PATIENT WAS TO SEE THE PHYSICIAN FOR A FOLLOW UP APPOINTMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BATTERY WAS STICKING OUT OF THE PATIENT'S PROFILE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL COMBINATIONS WITH ¿LEADS¿ 0 AND 2 MEASURED IMPEDANCES GREATER THAN 4,000 OHMS. NORMAL BATTERY DEPLETION WAS ALSO NOTED. BOTH THE IMPLANTABLE NEUROSTIMULATOR AND LEAD WERE REPLACED ON (B)(6), 2013. THE PATIENT OUTCOME OF THE REPLACEMENT PROCEDURE WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    183424 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention