BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3002280 · Received March 13, 2013

    Report

    Report Number
    3004209178-2013-03648
    Event Type
    Injury
    Date Received
    March 13, 2013
    Report Date
    February 26, 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V744239, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3093-28, LOT# V548215, IMPLANTED: (B)(6) 2010. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE CAUSE OF THE EVENT WAS THAT THE LEAD APPEARED TO BE IMPLANTED TOO DEEP (AND POTENTIALLY MISSING THE S3 NERVE) AND THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET WAS TOO SUPERFICIAL. REPROGRAMMING WAS PERFORMED MULTIPLE TIMES BY THE MANUFACTURER¿S REPRESENTATIVE AT THE PREVIOUS SURGEON¿S OFFICE. AN X-RAY WAS PERFORMED (RESULTS NOT REPORTED). IT WAS CONFIRMED THAT A REVISION WAS PERFORMED. IT WAS NOTED THAT THE PATIENT HAD IMPROVED IN TERMS OF PAIN AND SYMPTOM CONTROL. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT AND EXPERIENCED A DECREASE IN THERAPEUTIC BENEFIT DURING THE NIGHTTIME. THE PATIENT STATED THAT THE DEVICE HAD NOT BEEN WORKING VERY WELL, SO IT WAS MOVED FROM THE RIGHT SIDE TO THE LEFT SIDE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104645 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention