BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 5900648 · Received August 24, 2016

    Report

    Report Number
    3004209178-2016-17559
    Event Type
    Injury
    Date Received
    August 24, 2016
    Date of Event
    June 1, 2016
    Report Date
    October 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) STATING THAT THEY PATIENT HAD NOT BEEN SCHEDULED FOR DEVICE REPLACEMENT DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI) STATUS.

    Description of Event or Problem · 1

    A CONSUMER IMPLANTED FOR SPINAL PAIN REPORTED VIA THE MANUFACTURER'S REPRESENTATIVE (REP) SEEING THE ELECTIVE REPLACEMENT INDICATOR (ERI) MESSAGE IN (B)(6) OF 2016. IT WAS NOTED THE CONSUMER'S PROGRAMMED SETTINGS AND THERAPY IMPEDANCES RESULTS WERE: 4.9V, 450PW, 40HZ, 24HRS 548 OHMS, AND 8.822MA. A BATTERY CALCULATION WAS PERFORMED WITH THE FOLLOWING RESULTS: 4.5V: EST 25 MONTHS; 5.0V: EST 22 MONTHS. IT WAS NOTED THE BATTERY MEASUREMENT WAS 2.7 VOLTS, BUT THE DEVICE HAD BEEN OFF FOR TWO MONTHS. IT WAS NOTED CYCLING WASN'T PROGRAMMED AND THERE WAS NO SHORT CIRCUIT. IT WAS NOTED THE CONSUMER ONLY HAD ONE GROUP AND HAD NO CHANGES. IMPEDANCE RESULTS WERE TAKEN WHICH SHOWED 89, 1011, 89 1027, 810, 1181, 811, 1286, 910, 1053, 911, 1189, 1011, AND 1214. IT WAS RECOMMENDED TO DISCUSS THIS WITH THE HEALTHCARE PROVIDER (HCP) AND TO SEND THE INS IN FOR ANALYSIS DUE TO THE UNEXPECTED EARLY BATTERY DEPLETION. NO PATIENT SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT THOUGHT HIS FIRST INS "WOULD LAST 5 YEARS BUT IT DIDN'T", AND IT DEPLETED THE PREVIOUS YEAR. THE PATIENT CONFIRMED GETTING A NEW INS. NO SYMPTOMS WERE REPORTED. THERE WERE NO REPORTED COMPLICATIONS AND NO FURTHER COMPLICATIONS WERE EXPECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    551703 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention