BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4122233 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17809
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 5, 2014
    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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF LEAD MODEL 977A260, SERIAL #(B)(4), SHOWED NO ANOMALIES. ANALYSIS OF THE MULTI-LEAD TRIALING CABLE MODEL 355531, LOT # N478497 SHOWED NO ANOMALIES.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 355531, LOT# N478497, PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 977A260, SERIAL# (B)(4), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD COMPONENT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT FUNCTIONAL INTRAOPERATIVELY. SPECIFICALLY, HIGH IMPEDANCES (>10,000 OHMS) WERE OBSERVED ON ALL ELECTRODES ON INTRAOPERATIVELY WHEN TESTED WITH THE MULTI-LEAD TRIALING CABLE (MLTC). IT WAS NOTED THAT THE LEAD WAS PLACED CORRECTLY IN THE MLTC BUT THE HIGH IMPEDANCES PERSISTED. A DIFFERENT MLTC WAS USED BUT THE LEAD WAS ULTIMATELY REPLACED TO RESOLVE THE ISSUE. IT COULD NOT BE DETERMINED AT THE TIME OF REPORT IF THE MLTC OR THE LEAD WAS THE CAUSE OF THE HIGH IMPEDANCE ISSUE. THE PATIENT EXPERIENCED NEVER HAVING THERAPEUTIC EFFECT DURING THE EVENT. THE PATIENT WAS REPORTED AS DOING FINE ON FOLLOW UP. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600552 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR