BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3022041 · Received March 26, 2013

    Report

    Report Number
    6000032-2013-00070
    Event Type
    Injury
    Date Received
    March 26, 2013
    Report Date
    March 8, 2013
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3080, LOT# L94159, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 3080, LOT# L94159, IMPLANTED: (B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 3095-10, SERIAL# (B)(4). IMPLANTED: (B)(6) 2001, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL REVIEW INDICATED THAT THE EXPLANT WAS DUE TO AN MRI THAT THE PATIENT NEEDED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DID NOT HAVE CONCERNS WITH THEIR DEVICE OR THERAPY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS ADDED THAT THE PATIENT'S BATTERY WENT DEAD AND THE PATIENT LOST RELIEF OF THEIR SYMPTOMS. IT WAS STATED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED IN THE (B)(4) OF 2012. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    124472 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT SOFAMOR DANEK PUERTO RICO MFG 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00077 YR Required Intervention