BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2833687 · Received November 15, 2012

    Report

    Report Number
    6000032-2012-00194
    Event Type
    Injury
    Date Received
    November 15, 2012
    Report Date
    August 3, 2019
    Manufacturer
    MDT SOFAMOR DANEK PUERTO RICO MFG
    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

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3886, LOT# L93590, IMPLANTED: 2001-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2001-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 3031, SERIAL# (B)(4), IMPLANTED: 2001-(B)(6), PRODUCT TYPE PROGRAMMER, (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED IN 2006 DUE TO SCAR TISSUE BUILD-UP. NO OTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT INITIALLY HAD GOOD THERAPEUTIC BENEFIT BUT THEN EXPERIENCED DECREASED SENSATION. DESPITE NUMEROUS PROGRAMMING EFFORTS THE IMPLANTABLE NEUROSTIMULATOR (INS) NO LONGER PROVIDED ANY BENEFIT TO THE PATIENT. X-RAYS TAKEN SHOWED THAT THE LEAD HAD MIGRATED POSTERIORLY. A SURGICAL PROCEDURE WAS PERFORMED AT WHICH TIME IT WAS OBSERVED THAT THE LEAD APPEARED TO BE FIXED TO THE BONE AND DID NOT MOVE WHEN ATTEMPTING TO EXPLANT. THE PHYSICIAN THEN CUT THE LEAD AS CLOSE AS POSSIBLE TO THE OUTSIDE CAPSULE. A NEW LEAD WAS THEN SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT THE PATIENT TOLERATED THE PROCEDURE WELL AND WAS TRANSFERRED TO RECOVERY IN SATISFACTORY CONDITION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT SOFAMOR DANEK PUERTO RICO MFG 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention