BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 4153058 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18546
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    January 1, 2009
    Report Date
    September 17, 2014
    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
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377760, LOT# V006428, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V006428, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION. THE PATIENT REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY WAS DEAD BECAUSE THEY HAD NOT TURNED IT ON OR CHARGED IT IN A FEW YEARS DUE TO PROBLEMS WITH SHOCKING. THE HEALTHCARE PROFESSIONAL (HCP) DID A FEW REVISIONS AND THE PROBLEM WAS STILL UNRESOLVED AND THERE WOULD BE NO REASON TO REPLACE THE BATTERY AT THE CURRENT TIME. THE HCP REPLACED A FEW OF THE LEADS AND MOVED THE BATTERY FROM ONE HIP TO THE OTHER HIP AND THEN TO THE SIDE. WITH ALL OF THE REVISIONS, THE SHOCKING CONTINUED. THE SHOCKING STARTED ABOUT 5 YEARS PRIOR TO REPORT. THE PATIENT REPORTED NO FALLS OR TRAUMAS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632154 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention