BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 2990501 · Received March 5, 2013

    Report

    Report Number
    3004209178-2013-03355
    Event Type
    Injury
    Date Received
    March 5, 2013
    Report Date
    February 13, 2013
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3987A60, LOT# N310227, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S LEADS 'REPOSITIONED' ONE WEEK AFTER THEIR FIRST IMPLANT. IT WAS STATED THAT THE PATIENT HAD THREE SURGERIES SINCE IMPLANT IN (B)(6) 2012 INCLUDING ONE WHERE THE HEALTHCARE PROVIDER (HCP) MOVED THE IMPLANTABLE NEUROSTIMULATOR (INS) FROM 'THE RIGHT SIDE TO THE LEFT SIDE.' IT WAS ALSO STATED THAT THE PATIENT HAD FALLEN BUT THE DATE WAS UNKNOWN AT THE TIME OF REPORT. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93754 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 00069 YR Required Intervention