BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 1940830 · Received December 23, 2010

    Report

    Report Number
    3004209178-2010-10741
    Event Type
    Injury
    Date Received
    December 23, 2010
    Date of Event
    December 20, 2007
    Report Date
    May 30, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID : 377745 LOT# V071379016 IMPLANTED: (B)(6) 2007 EXPLANTED: PRODUCT TYPE: LEAD PRODUCT ID: 3708120 SERIAL# (B)(4) IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION, PRODUCT ID: 3550-29, LOT# : N129236 , IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY PRODUCT ID: 37742, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER, PATIENT PRODUCT ID: 37752, SERIAL#: (B)(4) IMPLANTED: (B)(6) 2007, -- PRODUCT TYPE: RECHARGER . PREVIOUS CODES NO LONGER APPLY: ALL CODES WERE UPDATED TO CURRENT STANDARDS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PT NEVER ACHIEVED THERAPEUTIC EFFECT FROM IMPLANTABLE NEUROSTIMULATOR THERAPY. ORIGINALLY, HER PAIN WAS DOWN TO HER LEGS, BUT THEN CHANGED. THE DECISION TO EXPLANT WAS PROMPTED BY THE NEED TO GET A MAGNETIC RESONANCE IMAGING DONE AND BECAUSE STIMULATION SENSATION MOVED TO A DIFFERENT AREA OF HER BODY. THE PT PLANNED TO GET AN IMPLANTED PUMP INSTEAD. THE DEVICE WAS EXPLANTED. THE PT WAS DOING GREAT AFTERWARDS. ADDITIONAL INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT STATING THAT THEY HAD A PAIN STIMULATOR BEFORE WHICH WAS REMOVED AS IT WAS SENDING SHOCK WAVES (PAIN) TO THEIR ARMS AND FINGERS. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Required Intervention IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT #: NJB024026V| IMPLANTED:| ACCESSORY: MODEL 37752, LOT #: NKA035267N| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT #: NJD061061N| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT #: V071379016| STIM ACCESSORY: MODEL 3550-29, LOT #: N129236