BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2190749 · Received July 26, 2011

    Report

    Report Number
    3004209178-2011-05785
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 1, 2010
    Report Date
    June 30, 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
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6), 2010, THAT THE PATIENT EXPERIENCED TELEMETRY ISSUES. AN OVERDISCHARGE OF THE IMPLANTABLE NEUROSTIMULATOR WAS SUSPECTED. A DIAGNOSTIC IMAGE (ANTERIOR/POSTERIOR VIEW) OF THE DEVICE WAS REVIEWED BY THE MANUFACTURER REPRESENTATIVE AND THE LEADS APPEARED TO BE "COMING OUT TO THE RIGHT." THE PATIENT WAS SEEN ON (B)(6), 2011, FOR A TRICKLE CHARGE. THE DEVICE WAS SUCCESSFULLY INTERROGATED AND EFFECTIVE STIMULATION WAS ACHIEVED AFTER REPROGRAMMING WAS PERFORMED. IT WAS REPORTED ON (B)(6), 2011, THAT IT WAS SUSPECTED THAT THE PATIENT'S DEVICE HAD BEEN OVERDISCHARGED SINCE (B)(6) 2010. AN OVERDISCHARGE WAS CONFIRMED TO HAVE OCCURRED IN (B)(6) 2010. PROBLEMS WITH RECHARGE COUPLING WERE THE PRIMARY REASON FOR THE OVERDISCHARGE. THE PATIENT ALSO HAD "MEDICAL ISSUES" UNRELATED TO THE DEVICE SYSTEM THAT "DISTRACTED" THE PATIENT FROM THE MAINTENANCE OF THE DEVICE. AFTER TWO COMPLETE PHYSICIAN MODE RECHARGES (PMR'S), THE DEVICE REMAINED IN OVERDISCHARGE. AFTER TWO USES OF THE ANTENNA LOCATOR FEATURE, A POWER ON RESET (POR) CONDITION WAS DISPLAYED ON THE RECHARGER. THIS, THEN, LED TO THE NORMAL RECHARGING SCREEN. THE POCKET SEEMED TO ALLOW FOR EXCESSIVE MOVEMENT OF THE DEVICE. COUPLING VARIED BETWEEN ZERO BARS AND EIGHT BARS. A FLIP WAS NOT CONFIRMED. A TRICKLE CHARGE WAS PERFORMED TO GET THE DEVICE FUNCTIONING AGAIN. THE PATIENT WAS INSTRUCTED ON RECHARGING THE DEVICE AND MONITORING THE CHARGE LEVEL. THE PATIENT WAS "DOING FINE." IT WAS LATER REPORTED THAT THE PATIENT'S DEVICE WAS REMOVED AND REPLACED. NORMAL BATTERY DEPLETION DID NOT OCCUR. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

    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 72 YR Required Intervention LEAD: MODEL 3888, LOT# V101636| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V101636| PROGRAMMER: MODEL 37743, LOT# NKE121792N| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB013093N| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB013091N| LEAD: MODEL 3888, LOT# V101636| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V101636| EXPLANTED:| IMPLANTED:| RECHARGER: MODEL 37752, LOT# NKA130383N