BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3132472 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08261
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 7, 2013
    Report Date
    May 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT# N350053, IMPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN ORDER TO COVER THE PATIENT¿S PAIN IN THE TAILBONE AREA, THE PATIENT BECAME INCONTINENT. THE DEVICE HAD BEEN REPROGRAMMED SEVERAL TIMES WHICH RESULTED IN A LOSS OF PAIN RELIEF. THE PATIENT WAS REFERRED TO A NEUROSURGEON TO HAVE HER PERCUTANEOUS LEADS REMOVED AND HAVE A PADDLE LEAD IMPLANTED. THE PHYSICIAN FELT THAT THE AMPLITUDE REQUIRED TO COVER HER TAILBONE PAIN IS CAUSING THE INCONTINENCE. THE PHYSICIAN FELT THAT A PADDLE LEAD WILL REDUCE THE AMPLITUDE AND RESOLVE THE INCONTINENCE. IT WAS FURTHER REPORTED THAT THE PATIENT HAD NOT SCHEDULED THE REVISION YET. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE CAUSE OF THE EVENT WAS THE PATIENT¿S REQUIREMENT FOR HIGH ENERGY STIMULATION. THERE WERE NO ABNORMAL IMPEDANCES. SURGICAL REVISION OF THE LEAD WAS PENDING. IT WAS NOTED THAT THE PATIENT WAS REPROGRAMMED ON (B)(6) 2013. IT WAS REPORTED THAT THE PATIENT EXPERIENCED LOSS OF BOWEL AND BLADDER CONTROL WHEN STIMULATION REACHED 8V, AND TURNING THE SCS RETURNED THE FUNCTION OF BLADDER AND BOWEL CONTROL. IT WAS NOTED THAT THERE WAS NO PATIENT INJURY. IT WAS LATER REPORTED THAT THE PATIENT WENT TO SEE THE NEUROSURGEON AND WAS NOT GOING TO PROCEED WITH A PADDLE LEAD. THE PATIENT WAS REPROGRAMMED AND PUT IN CYCLING MODE AND REPORTED GOOD COVERAGE AND NO INCONTINENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234147 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR