BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3133082 · Received May 29, 2013

    Report

    Report Number
    9614453-2013-01061
    Event Type
    Injury
    Date Received
    May 29, 2013
    Report Date
    May 5, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 4301-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 4301-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD. (B)(4). (B)(6). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD, LOT #PBP004332K, FOUND NO ANOMALY. ANALYSIS OF THE LEAD, LOT #PBP004336K, FOUND THE BODY CUT THROUGH AND SEGMENTED WITH NO SIGNIFICANT ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPLANTED COMPONENTS WERE USED AFTER THEIR "USE BY DATE" (UBD).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY DEPLETED AFTER 10 YEARS OF SERVICE LAST YEAR BUT COULD NOT BE TESTED "AT THE TIME". DURING THE PROCEDURE TO REPLACE THE INS, IT WAS FOUND THAT THE LEAD COMPONENTS WERE FRACTURED. THE LEADS WERE REPLACED ON (B)(6) 2013 AND IT WAS REPORTED THAT THE INS SYSTEM NOW WORKED AS REQUIRED (¿PROBLEM SOLVED¿). NO PATIENT INJURIES WERE REPORTED AND THE OUTCOME WAS NOTED AS RECOVERED WITHOUT SEQUELAE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236260 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW IPG MFG SWITZERLAND 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention