BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4977227 · Received August 6, 2015

    Report

    Report Number
    3004209178-2015-15586
    Event Type
    Injury
    Date Received
    August 6, 2015
    Date of Event
    October 14, 2014
    Report Date
    July 15, 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
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE FIRST EXTENSION (S/N (B)(4)) AND THE SECOND EXTENSION (S/N (B)(4)) FOUND NO SIGNIFICANT ANOMALIES, THE STIMULATION EXTENSION BODIES WERE CUT THROUGH, PRODUCT SEGMENTED. ALL CONDUCTORS ARE CUT AT 56.3 CM FROM THE PROXIMAL END. ALSO NOTED IS THAT THE OUTER INSULATION HAS SOME SUSPECTED SCAR TISSUE ATTACHED TO IT. THE INSULATION IS BROKEN AND THERE IS SUSPECTED SCAR TISSUE AROUND THE BREAK. DUE TO THE INDICATION, ¿IMPEDANCE MEASUREMENTS WERE NORMAL PRE-OPERATIVELY¿, IT CAN BE CONCLUDED THAT THE BREAK IN THE INSULATION WOULD HAVE OCCURRED DURING EXPLANT. SINCE THE CONDUCTORS ARE NOT INDIVIDUALLY INSULATED, AN IMPEDANCE TEST WITH BROKEN INSULATION WHILE STILL IMPLANTED WOULD RESULT IN LOW IMPEDANCE MEASUREMENTS BETWEEN CIRCUITS, NOT NORMAL IMPEDANCES." METHOD CODES: CONCLUSION CODE AND RESULT CODE NO LONGER APPLY.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708360AA, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708360AA, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3487A-33, LOT# V000574, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 3487A, LOT# J0104085V, IMPLANTED:(B)(6) 2001, PRODUCT TYPE: LEAD. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE HEALTHCARE PROVIDER (HCP) VIA THE MANUFACTURER'S REPRESENTATIVE (REP) REPORTED THE PATIENT HAD BEEN UNABLE TO USE THE STIMULATOR WITH GOOD COVERAGE SINCE OCTOBER WHEN HER BATTERY WAS CHANGED. AT ONE POINT, SHE HAD COVERAGE ONLY ON THE LEFT SIDE AND THE PATIENT COMPLAINED OF IMPROPER COVERAGE. HOWEVER, SHE WAS UNABLE TO GIVE A DATE FOR WHEN SHE QUIT FEELING STIMULATION COMPLETELY. ON THE DAY OF THE REPORT, THE PATIENT HAD THE QUADRIPOLE PERCUTANEOUS LEADS AND EXTENSIONS EXPLANTED AND REPLACED WITH A PADDLE LEAD WITH EXTENSIONS. THE ISSUE WAS IDENTIFIED AT THE TIME OF SURGERY WHEN THE INSULATION OF THE EXTENSION WAS COMPROMISED DUE TO SCARRING PER THE PHYSICIAN. IMPEDANCE MEASUREMENTS WERE NORMAL PRE-OPERATIVELY; HOWEVER, THE PATIENT REPORTED NOT FEELING STIMULATION. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT.

    Description of Event or Problem · 1

    RETURNED PRODUCT- NO NEW INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    521334 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR Required Intervention