BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3767753 · Received April 23, 2014

    Report

    Report Number
    3004209178-2014-07741
    Event Type
    Injury
    Date Received
    April 23, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 3998, LOT# V890048, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3998, LOT# V890048, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD BEEN MOVING OUT ITS SPACE FOR A LITTLE OVER A MONTH. THE IMPLANT SITE WAS SWOLLEN, AND THE INS WAS MOVING AROUND, "POKING OUT" AND SOMETIMES IT WOULD GET BUMPED AND THE PATIENT WOULD NOT BE ABLE TO CHARGE. TWO NIGHTS AGO, THE PATIENT COULD NOT GET THE INS LINED UP WITH THE ANTENNA AND WAS NOT ABLE TO CHARGE. THE SWELLING COMES AND GOES. THE BATTERY STILL HAD A LITTLE BIT OF CHARGE LEFT. IT WAS REPORTED WHEN THE ISSUE HAD STARTED THE PATIENT SAW THEIR DOCTOR AND HAD AN X-RAY AND EXAM AND THE HCP COULD NOT FIND ANYTHING WRONG. THE "OTHER DAY" THE PATIENT SAW THEIR PAIN THERAPY DOCTOR, WHO CONFIRMED WHAT WAS GOING ON.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS A DISCHARGED BATTERY. BATTERY DEPLETION WAS NOTED. THE BATTERY WAS REPLACED ON (B)(6) 2014. X-RAYS TAKEN ON THE DAY OF REPLACEMENT SHOWED THAT THE STIMULATOR BATTERY WAS IN THE PATIENT'S RIGHT ABDOMEN. THE PATIENT HAD EXPERIENCED A LOSS OF STIMULATION AND WAS UNABLE TO CHARGE. THE PATIENT REQUIRED HOSPITALIZATION DUE TO THE EVENT. THE PATIENT OUTCOME WAS LISTED AS NO INJURY. NO OUTCOME WAS 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
    246568 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Hospitalization| R