BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3443336 · Received November 1, 2013

    Report

    Report Number
    3004209178-2013-20053
    Event Type
    Injury
    Date Received
    November 1, 2013
    Date of Event
    September 12, 2013
    Report Date
    November 10, 2015
    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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 355029, LOT# N080418, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 377760, LOT # V016985, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 355029, LOT# N080418, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 377760, LOT# V016985, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO ADJUST STIMULATION AND SAW AN END OF SERVICE (EOS) MESSAGE. THE PATIENT SAW THIS AFTER SOME BURNING IN THE DEVICE POCKET AND NOTED THAT THE DEVICE WAS STILL CHARGED TO 75%. AFTER THE PATIENT WAS ASKED IF SHE HAD EVER HAD A "JUMP START" TO HER BATTERY, SHE RESPONDED THAT "THE REPRESENTATIVE TOLD HER OVER THE PHONE HOW TO DO SOMETHING SIX TO SEVEN MONTHS AGO BUT DID NOT REMEMBER HOW TO DO IT OR HAVE IT WRITTEN DOWN." THE PATIENT ALSO REPORTED THAT SHE WAS IN A LOT OF PAIN FOR THE LAST MONTH BECAUSE STIMULATION WAS NOT WORKING. THE PATIENT MENTIONED THAT THE DEVICE QUIT WORKING AT THE SAME TIME AS HER INTERSTIM DEVICE ON (B)(6) 2013. FOUR DAYS LATER IT WAS REPORTED THAT THE REPORTER WAS WITH THE PATIENT AT THE TIME OF THE REPORT. THE REPORTER STATED THAT THE RECHARGER WAS SHOWING THE DEVICE WAS 75%CHARGED BUT THE PATIENT PROGRAMMER SHOWED EOS. THE REPORTER TRIED TO INTERROGATE WITH THE CLINICIAN PROGRAMMER AND IT SHOWED THAT THE DEVICE WAS DISCHARGED. THE PATIENT LAST FELT STIMULATION ON (B)(6) 2013 BUT DID NOT STATE WHEN SHE LAST RECHARGED. THE PATIENT RECALLED HAVING ONE OVERDISCHARGE ABOUT "SIX MONTHS TO A YEAR AGO." THE REPORTER ASKED THE PATIENT IF SHE HAD PRESSED MULTIPLE BUTTONS ON THE RECHARGER IN ORDER TO DO A PHYSICIAN MODE RECHARGE (PMR) BEFORE, BUT THE PATIENT HAD NOT. THE PATIENT'S PAIN WAS NOT BEING COVERED. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURING REPORT #300420917 8-2013-20047 FOR THE PATIENT'S SIMILAR ISSUES WITH HER INTERSTIM DEVICE.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT SINCE 2012 SHE WAS HAVING PAIN ISSUES, THE PAIN WAS ALL OVER. THE PATIENT STATES SHE WAS TAKING MUSCLE RELAXERS. IN (B)(6) 2013, THE PATIENT STATED THE SPINAL CORD STIMULATOR (SCS) WAS TAKEN OUT. THE PATIENT STATED SHE WAS UPSET AND SHE DID NOT KNOW WHY IT WAS BEING TAKEN OUT. THE PATIENT WAS WONDERING IF THE PAIN WAS DUE TO THE SCS LEADS BEING TAKEN OUT. THE PATIENT ASKED ABOUT USING A TENS UNIT. THE PATIENT WAS TO FOLLOW UP WITH THE HEALTH CARE PROVIDER (HCP). MEDICAL HISTORY INCLUDES GASTROINTESTINAL/PELVIC FLOOR. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564259 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 00040 YR Required Intervention