BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4810895 · Received June 2, 2015

    Report

    Report Number
    3004209178-2015-10079
    Event Type
    Malfunction
    Date Received
    June 2, 2015
    Report Date
    May 14, 2015
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377845, LOT# V010268 SERIAL# IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708160, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING; EVERYTHING WAS CHARGED UP, BUT STIMULATION WOULD NOT TURN ON INSIDE OF HIS BODY. IT HAD NOT BEEN ON FOR ABOUT A WEEK, AND THE PATIENT HAD NOT BEEN ABLE TO TURN IT ON. REPORTED PATIENT SYMPTOMS INCLUDED A LOSS OF THERAPEUTIC EFFECT. DURING THE REPORT, THE PATIENT WAS GUIDED THROUGH TROUBLESHOOTING USING THE PATIENT PROGRAMMER TO TRY AND CHECK WHETHER STIMULATION WAS TURNED ON. WHEN SYNCED WITH THE PATIENT PROGRAMMER, THE PATIENT WAS ON PROGRAM A AT 6.6V. THE PATIENT PROGRAMMER BATTERY ICON SHOWED 75% BATTERY, THE INS ICON SHOWED THE INS BATTERY WAS AT 50%, AND THE ¿STIM OFF¿ ICON WAS IN THE UPPER LEFT CORNER. STIMULATION WAS DECREASED TO 2.80V, AND THE PATIENT WAS INSTRUCTED TO TURN STIMULATION BACK ON. THERE WAS A VISUAL CONFIRMATION OF THE ¿STIM ON¿ LIGHTNING BOLT ICON, BUT THE PATIENT WAS NOT FEELING STIMULATION AT ALL. STIMULATION WAS INCREASED TO 6.0V, BUT THE PATIENT STILL DID NOT FEEL ANY THERAPEUTIC EFFECT. THERE WERE NO REPORTED FALLS, TRAUMA, OR MEDICAL EVENTS. IT WAS NOTED THAT THE PATIENT HAD NO OTHER PROGRAMMING OPTIONS TO TRY. ON (B)(6) 2015, THERE WERE HIGH IMPEDANCE VA LUES OF >40,000 OHMS ON CONTACTS 6, 7, AND 8, AND THERE WAS A LOSS OF THERAPEUTIC EFFECT. AFTER REPROGRAMMING TO CONTACTS 4 AND 5, STIMULATION WAS ¿WORKING GOOD NOW.¿ THERE WAS A LOSS OF STIMULATION ON (B)(6) 2015, AND THE ISSUE WAS RESOLVED WITH REPROGRAMMING. THE CAUSE OF THE HIGH IMPEDANCE VALUES WAS UNKNOWN. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355557 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00052 YR