BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2230573 · Received August 12, 2011

    Report

    Report Number
    3004209178-2011-06295
    Event Type
    Injury
    Date Received
    August 12, 2011
    Date of Event
    June 9, 2011
    Report Date
    July 21, 2011
    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
    NH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A LOSS OF THERAPEUTIC EFFECT AND TELEMETRY ISSUES WERE REPORTED. SYMPTOMS ASSOCIATED WITH THE EVENT INCLUDED RETURN OF INCONTINENCE AND NO SENSATION FROM DEVICE. A POSSIBLE IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT WAS SUGGESTED. ADDITIONAL INFO RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN. IMPEDANCE MEASUREMENTS WERE NOT ABLE TO BE PERFORMED SINCE TELEMETRY COULD NOT BE ESTABLISHED. REPROGRAMMING WAS DONE ON (B)(6) 2011 AND THERE WAS NO TELEMETRY. AN MRI/X-RAY/CT SCAN WAS DONE ON (B)(6) 2011 AND NORMAL RESULTS WERE OBTAINED. A SURGICAL INTERVENTION OCCURRED AND A REVISION AND REPLACEMENT OF THE ENTIRE INS SYSTEM WAS DONE ON (B)(6) 2011. FULL RESPONSE AND RELIEF OF SYMPTOMS OCCURRED FOLLOWING THE REPLACEMENT. THE PT DID NOT REQUIRE HOSPITALIZATION AND THERE WAS NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention EXPLANTED:| EXTENSION: MODEL 3095, LOT # NAH032955V| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3031, LOT # NBW003724P| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3080, LOT # L73030| IMPLANTED: