BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 4110289 · Received September 23, 2014

    Report

    Report Number
    3004209178-2014-17532
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3 7754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3550-29, LOT# N369615, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY; PRODUCT ID 97791, LOT# N375843, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT FELL FORWARD ON (B)(6) 2014 AND DID THE SPLITS. THEIR IMPLANTABLE NEUROSTIMULATOR (INS) HAD MOVED DOWN AND THE DEVICE WAS DEEPER AT THE TIME OF THE REPORT. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    592485 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 00059 YR