BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2073573 · Received April 26, 2011

    Report

    Report Number
    3004209178-2011-03103
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    January 1, 2011
    Report Date
    December 1, 2017
    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 THE PT HAD NEVER HAD THERAPEUTIC EFFECT. THE PT "CAME OUT OF SURGERY WITH A HOLE IN HER SPINE". IT WAS NOTED THAT THE PT HAD 3 REVISION SURGERIES. THE PT WAS HAVING THE STIM EXPLANTED AND WAS GOING TO TRY A PUMP TRIAL. THE PT WAS AT HOME AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION WAS REQUESTED.

    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 80 YR Female Required Intervention ACCESSORY: MODEL 37752, LOT# NKA146402N.| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB084023V.| EXTENSION: MODEL 37081, LOT# NJB084024V.| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 39565-30, LOT# N183687004.| LEAD: MODEL 39565-65, LOT# V585126001.| PROGRAMMER: MODEL 37743, LOT# NKE157108N.| UNKNOWN: MODEL UNK, LOT# N201428.| EXPLANTED:| UNKNOWN: MODEL UNK, LOT# N201428| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB084024V| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB084023V| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA146402N| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE157108N| EXPLANTED:| LEAD: MODEL 39565-65, LOT# V585126001| EXPLANTED:| LEAD: MODEL 39565-30, LOT# N183687004| EXPLANTED:| IMPLANTED: