BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2153442 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04611
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 24, 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
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOWING A STIMULATOR REPLACEMENT (SEE MFR REPORT # 3004209178-2011-03571), THE PATIENT WAS FIRST ABLE TO USE THE NEW STIMULATOR 5 WEEKS AFTER THE REPLACEMENT, BUT THE PATIENT PROGRAMMER WAS BLANK. THE STIMULATION COULD NOT BE ADJUSTED, AND SEVERAL SETS OF BATTERIES WERE USED IN THE PATIENT PROGRAMMER. IT IS UNCLEAR IF THE ISSUE WAS RESOLVED. ABOUT A MONTH LATER, THE STIMULATOR WENT "BALLISTIC" ON THE RIGHT SIDE WHILE THE PATIENT WAS SITTING IN BED. THE STIMULATOR WENT TO "FULL" POWER, AND THE PATIENT COULD NOT MOVE THE RIGHT LEG. THE PATIENT ALSO HAD A SPASM ON EVERY MUSCLE ON THE RIGHT SIDE, AND THE TOES CURLED ON THE RIGHT FOOT. THE FOLLOWING DAY, THE STIMULATOR WAS TURNED BACK ON AND IT WENT "BALLISTIC" A SECOND TIME. THE SETTINGS WERE LOWERED FROM 3.95V TO 0.9V, AND THE DEVICE WAS STILL GOING BALLISTIC. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THE EVENT. THE DEVICE WAS TURNED OFF. ABOUT ANOTHER MONTH LATER, THE PATIENT MET WITH A MEDTRONIC REPRESENTATIVE. THE REPRESENTATIVE REPORTED THERE WAS A SHOCKING OR JOLTING SENSATION AND AN OVERSTIMULATION SENSATION. THIS OCCURRED 3 TIMES: 2 TIMES IN THE PATIENT'S HOME, AND 1 TIME AT (B)(6) (BUT NOT NEAR A THEFT SECURITY GATE) ON (B)(6) 2011. THE FIRST 2 INSTANCES WERE ON CONSECUTIVE DAYS, AND THE DEVICE WAS TURNED OFF. IT IS UNCLEAR IF THE FIST 2 INSTANCES REFER TO THE SAME EVENT AS THE 2 TIMES, THE STIMULATOR WENT "BALLISTIC" ON CONSECUTIVE DAYS A MONTH PRIOR. THE DEVICE WAS TURNED BACK ON 3 WEEKS LATER, AND SHORTLY AFTERWARDS, THE 3RD SHOCKING EVENT TOOK PLACE. TWO OF THE SHOCKING VENTS BROUGHT THE PATIENT TO HER KNEES, BUT IT IS NOT CLEAR WHICH TWO. THE PATIENT HAD A HEATING SENSATION AT THE STIMULATOR SITE THAT COINCIDED WITH THE SHOCKING EPISODES. THE PATIENT WAS FEARFUL OF TURNING THE STIMULATION BACK ON. THE IMPEDANCES WERE MEASURED AND ELECTRODES 13 AND 15 WERE >10,000 OHMS. THE LEFT SIDE AMPLITUDE WAS "GOOD" AT 3.3V, BUT THE RIGHT SIDE AMPLITUDE PRODUCED LITTLE TO NO PARESTHESIA UP TO 8.5V. X-RAYS WERE GOING TO BE PERFORMED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR LEAD: MODEL 3778, LOT# V116594019| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37702, LOT#UNK| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA036589N| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB016598V| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3778, LOT# V007368| PROGRAMMER: MODEL 37743, LOT# NKE101787N| EXTENSION: MODEL 37081, LOT# NJB016597V| IMPLANTABLE NEURO STIMULATOR: MODEL 37712| EXPLANTED:| IMPLANTED:| LOT# NKF704085H