BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1842080 · Received September 20, 2010

    Report

    Report Number
    3004209178-2010-07107
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    December 9, 2008
    Report Date
    December 29, 2009
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAD REPLACEMENT DUE TO SUSPECTED LEAD FRACTURE DUE TO INCREASED IMPEDANCES. THE PT REPORTED SHE WAS BATTLING BLADDER INFECTIONS. THE EVENT WAS ATTRIBUTED TO THE LEAD. THE LEAD WAS REVISED (B)(6) 2008 AND THERE WAS REPROGRAMMING. PT SYMPTOMS WERE: RECOVERY OF BLADDER SYMPTOMS. PT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL LEAD URO, LOT# UNK| LEAD: MODEL 3093, LOT# V048607| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD051863N