BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2190343 · Received July 25, 2011

    Report

    Report Number
    3004209178-2011-05733
    Event Type
    Injury
    Date Received
    July 25, 2011
    Date of Event
    January 1, 2011
    Report Date
    October 13, 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
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE NEUROSTIMULATOR MODEL 37712 SERIAL# (B)(4) SHOWED NO SIGNIFICANT ANOMALIES. THE DEVICE WAS FUNCTIONALLY OK, BUT THE BATTERY HAD REDUCED CAPACITY DUE TO OVERDISCHARGE. NO TELEMETRY WAS OBSERVED WITH A CLINICIAN PROGRAMMER. NO OUTPUT WAS OBSERVED ON ANY ELECTRODE PAIR TESTED WITH A KNOWN GOOD LEAD. THE DEVICE DID NOT SYNC WITH A PATIENT PROGRAMMER, AND WAS UNABLE TO PERFORM A NORMAL RECHARGE WITH A RECHARGER. A POWER ON RESET (POR) OCCURRED AND THE DEVICE WAS RECHARGED USING A PHYSICIAN MODE RECHARGE (PMR). A NORMAL RECHARGE SESSION WAS PERFORMED. GOOD, STABLE OUTPUT WAS THEN OBSERVED ON EACH ELECTRODE. A NON-STANDARD TEST WAS DONE TO ADDRESS THE COMPLAINT RELATED TO TROUBLE WITH RECHARGING. RECHARGING OF THE DEVICE WAS DONE AT SPACINGS OF 0 CM, 1 CM, 2 CM, AND 3 CM TO SEE HOW MANY COUPLING BARS COULD BE OBTAINED. AT 0 CM THERE WERE 8 BARS, AT 1 CM THERE WERE 8 BARS, AT 2 CM THERE WERE 4 BARS, AND AT 3 CM THERE WERE 0 BARS. THE SAME COUPLING WAS OBSERVED ON A KNOWN GOOD NEUROSTIMULATOR, INDICATING THAT THE DEVICE WAS WORKING CORRECTLY WITH A RECHARGER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WAS A PROBLEM RECHARGING. THERE WAS TROUBLE COUPLING AND/OR COMMUNICATION ISSUES. PT LEFT STIMULATION OFF FOR 6 MONTHS AND AN OVERDISCHARGE WAS SUSPECTED. THE DEVICE WAS EXPLANTED (B)(6) 2011 AND A NEW DEVICE WAS IMPLANTED. THE DEVICE QUIT WORKING AND THEY WERE UNABLE TO MAKE ANY COMMUNICATION SO THE HCP DECIDED TO REPLACE THE BATTERY. SINCE REIMPLANT, THE PT HAD GOOD STIMULATION. ADDITIONAL 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 STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention PROGRAMMER: MODEL 37743, LOT# NKE105639N| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB024321V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB029851V| EXPLANTED:| EXPLANTED:| LEAD: MODEL 39565-30, LOT # N135543006| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA021048N