BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 5779935 · Received July 8, 2016

    Report

    Report Number
    3004209178-2016-13826
    Event Type
    Malfunction
    Date Received
    July 8, 2016
    Report Date
    July 8, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3998, LOT# VA055F0, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3986A, LOT# N303867, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PATIENT NOTICED A LOSS OF COVERAGE A FEW MONTHS AGO AND THEIR HEALTH CARE PROFESSIONAL (HCP) WAS PROGRAMMING AROUND THE HIGH IMPEDANCES. THERE WERE IMPEDANCES ON (B)(6) 2016. THE PATIENT WAS IN FOR A REVISION OF THEIR LEAD. THE MANUFACTURER REPRESENTATIVE (REP) NOTED THAT WHEN THE LEAD WAS FIRST TESTED ALL IMPEDANCES WERE 770-1295 OHMS RANGE EXCEPT FOR CONTACT 1. EVERYTHING WITH 1 WAS SHOWING GREATER THAN 10,000 OHMS. THE HCP HAD ALREADY PLANNED TO REPLACE THE LEAD SINCE THE PATIENT HAD ISSUES IN THE PAST WITH 0-3 BEING HIGH AND THE PATIENT HAD LOSS COVERAGE. ONCE THE HCP REPLACED THE LEAD IMPEDANCES WERE STILL IN 770-1295 RANGE WITH THE EXCEPTION OF 1 BEING AT GREATER THAN 10,000. THEY WENT IN AND SWITCHED THE IMPLANTABLE NEUROSTIMULATOR (INS). THEY WENT TO TEST AT THAT POINT, 1 AND 7 CONTACTS WERE SHOWING GREATER THAN 10,000 OHMS. THEY TRIED TESTING AT 3V AND THEY SHOWED GREATER THAN 40 ,000 OHMS. THE SAME ISSUES SEEN IF TESTING LEAD IMPEDANCE WITH SCREENING CABLE/EXTERNAL NEUROSTIMULATOR (ENS). THEY WENT BACK TO TEST THE EXTENSION AS WELL AS LEAD ONLY AND AGAIN 1 AND 7 WERE SHOWING 10,0000 OHMS. IT WAS NOTED THAT THE HCP WAS REPROGRAMMING AROUND THE HIGH IMPEDANCES. OTHER RELEVANT MEDICAL HISTORY INCLUDES COMPLEX REG PAIN SYNDROME. RELATED REPORTS:3004209178-2016-13825.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433536 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97712

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR