BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORESENSOR MRI

    MDR report key: 4190454 · Received October 21, 2014

    Report

    Report Number
    3004209178-2014-20115
    Event Type
    Malfunction
    Date Received
    October 21, 2014
    Report Date
    September 30, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 97791, LOT# N452165, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: ACCESSORY. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAD MIGRATION. THE HEALTHCARE PROVIDER (HCP) DID AN X-RAY AND REPORTED THAT THE PADDLE SHIFTED TO THE RIGHT. THE PATIENT WAS NOT GETTING GOOD COVERAGE ON THE LEFT SIDE OF HER ARM. THE PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY AND THE PATIENT SYMPTOM INCLUDED LESS THAN 50% THERAPY RELIEF AT THE LEFT SIDE OF THE IMPLANT. IT WAS UNKNOWN WHY THE LEAD MIGRATED. THE PATIENT WENT TO THEIR ONE MONTH POST-OPERATIVE WITH THE HCP. THE PATIENT HAD AN APPOINTMENT PLANNED FOR (B)(6). IT WAS LATER REPORTED THAT REPROGRAMMING WAS PERFORMED AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667586 RESTORESENSOR MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR