BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 4377488 · Received January 2, 2015

    Report

    Report Number
    3004209178-2015-00005
    Event Type
    Injury
    Date Received
    January 2, 2015
    Report Date
    December 11, 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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37744, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3986A, LOT# N182431, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SURGERY THE WEEK PRIOR TO THE REPORT TO HAVE THEIR IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED AND BELIEVED THAT THE LEAD WAS ALSO REPLACED OR MOVED IN THEIR NECK. THEY DID NOT KNOW IF THE LEADS WERE REPLACED OR JUST MOVED BECAUSE THE WIRES WERE COILED BECAUSE THEY HAD LOST A LOT OF WEIGHT. IT WAS KNOWN THAT THEY WERE MOVED DOWN. THE PATIENT LOST SO MUCH WEIGHT THAT IT WAS TURNING SIDEWAYS NOT UP AND DOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR Required Intervention