BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2223857 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06535
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    January 1, 2011
    Report Date
    October 4, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AFTER THE PT'S IMPLANTABLE NEUROSTIMULATOR WAS IMPLANTED IN SURGERY, IMPEDANCE MEASUREMENTS OF ELECTRODES 0/13 AND 0/14 WERE OUT OF RANGE. THE LEAD THAT HAD JUST BEEN IMPLANTED DURING THE SAME PROCEDURE (MODEL UNK, LOT# UNK) WAS REMOVED AND REPLACED. AFTER THE NEW LEAD (MODEL 39565, LOT# V626185009) WAS PLACED, ALL IMPEDANCE READINGS WITH REFERENCE ELECTRODE 0 WERE GREATER THAN 10,000 OHMS. THE REFERENCE ELECTRODE WAS CHANGED AND THE IMPEDANCE MEASUREMENTS WERE WITHIN NORMAL LIMITS (BETWEEN 700 AND 1,200 OHMS). THE MFR REP PROGRAMMED THE PT'S DEVICE. THE PT FELT STIMULATION AND WAS "SATISFIED". THE ISSUE WAS RESOLVED. SEE MFR REPORT # 3004209178-2011-06533 FOR INFO RELATED TO THE PREVIOUSLY IMPLANTED NEUROSTIMULATOR AND ASSOCIATED EVENTS DURING THE SAME SURGICAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention EXPLANTED.| EXPLANTED: | EXPLANTED: | IMPLANTED.| IMPLANTED: | IMPLANTED: | LEAD: MODEL 39565, LOT# V626185009.| LEAD: MODEL 39565-651, LOT # V582460011.| LEAD: MODEL UNK, LOT# UNK.| PROGRAMMER: MODEL 37743, LOT# NKE143159N.| RECHARGER: MODEL 37752, LOT# NKA137455N.| EXPLANTED:| RECHARGER: MODEL 37752, LOT# NKA137455N| LEAD: MODEL 39565, LOT# V626185009| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE143159N| EXPLANTED:| LEAD: MODEL UNK, LOT# UNK| IMPLANTED: