BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3693778 · Received March 21, 2014

    Report

    Report Number
    3004209178-2014-04857
    Event Type
    Injury
    Date Received
    March 21, 2014
    Date of Event
    February 21, 2014
    Report Date
    April 9, 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
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-45, LOT# V482979, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3888-45, LOT# V482979, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3708220, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION; PRODUCT ID 3888-45, LOT# V482979, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3888-45, LOT# V482979, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS ON VACATION AND FELL ON A SLIPPERY FLOOR. IT WAS REPORTED THERE WERE CHANGES IN THEIR STIMULATION PATTERNS FOLLOWING THE FALL. IT WAS NOTED THE PATIENT HAS TWO SUBCUTANEOUS LEADS AND 1 EPIDURAL LEAD. IT WAS NOTED THAT ONE ELECTRODE ON THE SUBCUTANEOUS LEADS HAD HIGH IMPEDANCES. IT WAS NOTED THAT THE ELECTRODE WAS PROGRAMMED AROUND TO GET COVERAGE. IT WAS NOTED THERE WERE CHANGES IN STIMULATION WITH THE EPIDURAL LEAD. IT WAS REPORTED THAT WITH HIGHER AMPLITUDES THE PATIENT FEELS ¿CRAMPING¿ SENSATIONS ACROSS THEIR MIDBACK AND THIS SENSATION WAS NOT FELT PRIOR TO THEIR FALL. IT WAS NOTED THAT THE PATIENT WAS SCHEDULED FOR X-RAYS ON THE DAY OF REPORT. IT WAS FURTHER REPORTED THE PATIENT EXPERIENCED A LOSS OF STIMULATION/THERAPEUTIC EFFECT. ADDITIONAL INFORMATION RECEIVED REPORTED THE X-RAYS SHOWED THE LEADS HAD NOT APPEARED TO MOVE. IT WAS NOTED THE HEALTH CARE PROVIDER (HCP) FEELS THE PATIENT IS GETTING ¿DEZ STIMULATION¿ CAUSING THEIR THORACIC SYMPTOMS AND WILL NEED TO REPLACE THE EPIDURAL LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD BEEN REVISED ONE WEEK PRIOR TO REPORT HOWEVER NO FURTHER INFORMATION WAS REPORTED. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD ONE EPIDURAL LEAD AND BATTERY REPLACED ONE WEEK PRIOR TO REPORT. IT WAS REPORTED THE PATIENT IS NOW RECEIVING GOOD COVERAGE WITH THEIR STIMULATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS SCHEDULED FOR A LEAD REVISION DURING THE FIRST WEEK OF (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169617 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 00059 YR Required Intervention