BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4213638 · Received October 30, 2014

    Report

    Report Number
    3004209178-2014-20652
    Event Type
    Injury
    Date Received
    October 30, 2014
    Report Date
    February 6, 2017
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), EXPLANTED: 2014 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATION FROM THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS INTERMITTENT AND SOMETIMES TURNED OFF. THE MANUFACTURER¿S REPRESENTATIVE MET WITH THE PATIENT ¿AWHILE BACK¿ TO CHECK THE INS SYSTEM BUT WAS UNABLE TO FIND ANYTHING WRONG. THE REPRESENTATIVE THEN CHECKED THE INS SYSTEM AND THE IMPEDANCES AND AGAIN FOUND NOTHING WRONG. IT WAS NOTED THAT THE PATIENT WAS GETTING GOOD STIMULATION COVERAGE WITH THE DEVICE SYSTEM. IT WAS UNKNOWN WHEN THE ISSUE STARTED OR IF THE ISSUE WAS A SUDDEN OR GRADUAL ONSET. THE PHYSICIAN THEN DECIDED TO REPLACE THE ENTIRE INS SYSTEM WHERE IT WAS REPORTED THAT THERE WAS GOOD PLACEMENT OF THE NEW LEAD AND THAT THE PATIENT WAS GETTING EFFECTIVE STIMULATION COVERAGE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON 2017-01-30 REPORTING THAT THE FIRST BATTERY HAD TO BE REPLACED BECAUSE IT WAS FAULTY AND KEPT CUTTING OUT. THE DATE WAS ASKED BUT UNKNOWN. THE FIRST ONE HAD REGULAR ¿SUB CU¿ LEADS BUT NOW THE PATIENT HAD PADDLE LEADS IN C1 AND C2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695765 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 Required Intervention