BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6570383 · Received May 16, 2017

    Report

    Report Number
    3004209178-2017-10404
    Event Type
    Injury
    Date Received
    May 16, 2017
    Date of Event
    August 28, 2015
    Report Date
    September 21, 2017
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3887-45, LOT# V132668, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2017, 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

    IT WAS DETERMINED THAT REPORT NUMBER 3004209178-2017-18118 AND 3004209178-2017-18121 CONTAINED A DUPLICATE OF THE EVENT CONTAINED WI THIN THIS REPORT (REPORT NUMBER 3004209178-2017-10404). TO THIS END, IF ANY ADDITIONAL INFORMATION IS RECEIVED, IT WILL BE SUBMITTED UNDER REPORT NUMBER 3004209178-2017-10404, RATHER THAN 3004209178-2017-18118 AND 3004209178-2017-18121. 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

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR NON-MALIGNANT PAIN. IT WAS REPORTED THAT THEY WERE REPLACING THE PATIENT'S BATTERY ABOUT 6 MONTHS AGO AND AT THAT TIME FOUND THE ELECTRODES WERE OUT OF RANGE, >10000 OHMS. THE LEADS WERE NOT REPLACED AT THAT TIME. AT A PROCEDURE ABOUT 1 MONTH AGO, THE LEADS WERE REPLACED BUT THE PATIENT HAD NOT CHARGED THE BATTERY IN BETWEEN THE TWO PROCEDURES. NO SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP STATING 2 NEW LEADS WERE IMPLANTED ALONG WITH TWO NEW BATTERIES. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP. IT WAS REPORTED THAT THE HIGH IMPEDANCES WERE ONLY WITH ONE SYSTEM, IT WAS UNKNOWN WHICH ONE IT WAS. THE LEAD REPLACEMENT THAT OCCURRED ON (B)(6) 2017 WAS RELATED TO THOSE HIGH IMPEDANCES. THE PROVIDED INFORMATION WAS CONFIRMED WITH PATIENT'S HCP. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION FROM THE HEALTHCARE PROFESSIONAL OF THE CLINICAL STUDY CONFIRMED THAT THE INS THAT WAS MODIFIED HAS THE SERIAL (B)(4). THE LEADS THAT WERE MODIFIED HAVE LOT NUMBER V132668.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    351362 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention