BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2102618 · Received May 23, 2011

    Report

    Report Number
    3004209178-2011-03740
    Event Type
    Malfunction
    Date Received
    May 23, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ONE OF THE PT'S LEADS BROKE FREE AND WAS TANGLED. THE LEAD WAS CAUSING THE PT PROBLEMS. THE PT REQUESTED PROGRAMMING TO HAVE THE LEAD SHUT OFF. THE PT REPORTED THAT SHE MAY HAVE TWISTED WRONG CAUSING THIS TO HAPPEN. PT REPORTED SHE HAD ISSUE WITH MOVEMENT AND WAS EXPERIENCING SHOCKING AND JOLTING AT IMPLANTABLE NEUROSTIMULATOR. THIS HAPPENED FOLLOWING A POSITION CHANGE. THE HEALTH CARE PROVIDER WOULD LIKE THE LEAD PROGRAMMED OFF. PER DIRECTIVE OF HER HEALTH CARE PROVIDER PT TURNED DOWN HER STIMULATION ON THE LEADS TO 0.0. LATER, THE PT STATED HER DEVICE HAD BEEN OFF FOR 4 DAYS AND SHE WAS IN PAIN. COMPANY REP WAS TO MEET WITH PT TO TAKE CARE OF THE LEAD AND TO REMOVE PROGRAMMING SO IT ADDRESSED PT NEED. THE PT'S STATUS WAS UNDETERMINED. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB008150V| ACCESSORY: MODEL 37752, LOT# NKA149809N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# V553163002| IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE161798N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V597860| LEAD: MODEL 3888, LOT# V597860