BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 5000163 · Received August 13, 2015

    Report

    Report Number
    3004209178-2015-15924
    Event Type
    Injury
    Date Received
    August 13, 2015
    Date of Event
    June 1, 2015
    Report Date
    July 21, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 377860, LOT# V004741, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 377860, LOT# V003916, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 377860, LOT# V004741, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 377860, LOT# V003916, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURING REPRESENTATIVE (REP) REPORTED THAT THE PATIENT'S RIGHT LEAD HAD HIGH IMPEDANCES. THE RIGHT LEAD CONTACTS 8, 10, 12, AND 14 READ > 10000 OHMS. THE OTHER CONTACTS ON THE RIGHT LEAD (9, 11, 13, 15) WERE NORMAL. THE LEFT LEAD WAS FINE. THE REP REPORTED HE HAD REPROGRAMMED AROUND THE HIGH IMPEDANCE ELECTRODES, BUT THIS WAS NOT EFFECTIVE FOR THE PATIENT'S THERAPY. THE PARESTHESIA AREA HAD MOVED AND THE PATIENT NOW FELT STIMULATION IN A HIGHER AREA THAN BEFORE. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT HAD A RECENT MEDICAL TEST OR ELECTROMAGNETIC INTERFERENCE EXPOSURE. THE PATIENT RECENTLY HAD A CT SCAN. IT WAS REVIEWED WITH THE REP THAT RUNNING IMPEDANCES AT A HIGHER VOLTAGE MAY GIVE BETTER INFORMATION. THE REP WAS ADVISED THAT IMAGING OF THE LEAD MAY BE PERFORMED. FURTHER INFORMATION RECEIVED FROM THE REP REPORTED THAT IT WAS THOUGHT THE LEAD MIGRATED AND THE HEALTH CARE PROFESSIONAL WAS GOING TO SCHEDULE A REVISION. RELEVANT MEDICAL HISTORY REPORTED WAS SPINAL PAIN. IF ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTH CARE PROFESSIONAL (HCP) INDICATING THAT THE PATIENT HAD A LEAD REVISION TWO WEEKS PRIOR TO THE REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534021 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 00079 YR Required Intervention