BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 8087752 · Received November 19, 2018

    Report

    Report Number
    3004209178-2018-25787
    Event Type
    Injury
    Date Received
    November 19, 2018
    Date of Event
    November 11, 2018
    Report Date
    February 8, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT HAS BEEN REFERRED TO THE PHYSICIAN'S PARTNER FOR A 2ND OPINION. THE CAUSE OF THE POOR COMMUNICATION WAS DUE TO THE PATIENT'S DEVICE NOT BEING CHARGED THE DAY IN WHICH WE WERE ABLE TO COMMUNICATE WITH THE INS. THE REP IS NOT SURE AT THIS POINT WHY THEY ARE NOT ABLE TO BRING BACK STIMULATION. THE IMPEDANCE CHECKED WAS CONDUCTED AT EACH VOLTAGE AND EACH TIME THE NUMBER WAS NORMAL BUT ELEVATED, SO THEY PROGRAMMED THE LEAD AN INCREASED INTENSITY. THE PATIENT FELT NOTHING. NOTHING HAS BEEN DONE AT THIS POINT THE RESOLVE NOT BEING ABLE TO COMMUNICATE. NO FURTHER INFORMATION WAS REPORTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3487A-45, LOT#: J0343940V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3487A-45, SERIAL/LOT #: (B)(4), UBD: 14-OCT-2007, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3487A-45, LOT# J0343940V, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2018. PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT IS UNABLE TO FEEL ANY STIMULATION. THE CALLER TRIED PROGRAMMING THE LOWER RESISTIVE CONTACTS WITH NOW SENSATION TO 10.5V. THE PATIENT'S IMPEDANCE TESTING SHOWED: 01=2135 02=3662 03= 6163 12= 1798 13= 4535 23= 3276 PALPATION PROVIDED NO CHANGES IN THERAPY. THE CALLER REPORTED THAT THE PATIENT FALLS A LOT, BUT DOES NOT ATTRIBUTE THEIR LOSS OF STIMULATION TO A FALL. REVISION SURGERY WAS DISCUSSED DUE TO THE AGE OF THE LEAD/EXTENSION. NO FURTHER INFORMATION WAS REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THE PATIENT WAS NOT ABLE TO FEEL STIMULATION ANY MORE. PATIENT HAD A FALL WHICH MAY HAVE LED TO THE LOSS OF THERAPY. IT WAS REPORTED THAT THE PATIENT HAD THE APPOINTMENT AND HAD NOT CHARGED THE DEVICE SO THE REP WAS NOT ABLE TO COMMUNICATE WITH THE DEVICE (B)(6) 2018. THE PHYSICIAN ORDERED IMAGES OF THE LEADS AND HAD THE PATIENT FOLLOW UP WITH HIM THE SAME DAY. AFTER DETERMINING THAT LEADS HAD NOT MOVED THE PHYSICIAN OFFICE CONTACTED REP TO INTERROGATE THE DEVICE. AT THE APPOINTMENT IT WAS DETERMINED THAT ONE OF THE PATIENT'S LEAD WAS COMPLETELY FRACTURED AND THE OTHER LEADS IMPEDANCE WERE WELL WITHIN RANGE BUT THE WHEN REP ATTEMPTED TO BRING STIMULATION TO PERCEPTION IT WAS UNSUCCESSFUL. REP REPROGRAMMED UP AND DOWN THE LEAD BUT COULD NOT BRING STIMULATION TO PERCEPTION (B)(6) 2018. THE ISSUE HAS NOT BEEN RESOLVED AT THE TIME OF THIS EVENT. NO SURGICAL INTERVENTION HAS OCCURRED AN UNKNOWN IF SURGICAL INTERVENTION IS PLANNED. NO FURTHER PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED IN THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS REPORTED THAT THE PATIENT HAD HER SPINAL CORD STIMULATOR (SCS) REPLACED ON (B)(6) 2018. ALL OF THE PATIENT'S ISSUES HAVE BEEN RESOLVED AS A RESULT OF THEIR SYSTEM BEING REPLACED. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    926814 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention