BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1X8 SUBCOMPACT LEAD

    MDR report key: 6546633 · Received May 4, 2017

    Report

    Report Number
    6000153-2017-00020
    Event Type
    Injury
    Date Received
    May 4, 2017
    Date of Event
    April 26, 2016
    Report Date
    June 14, 2017
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 377645, LOT # V003615, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2016, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

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

    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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN, FAILED BACK SURGERY SYNDROME, POSTLAMINECTOMY PAIN, COMPLEX REGIONAL PAIN SYNDROME TYPE I, AND CHRONIC LOW BACK PAIN. IT WAS REPORTED THAT THE PATIENT UNDERWENT A BATTERY REPLACEMENT SURGERY ON (B)(6) 2016 AND THEY ALSO REPLACED THE LEADS. THE IMPLANTABLE NEUROSTIMULATOR REPLACEMENT WAS DUE TO NORMAL BATTERY DEPLETION; HOWEVER, THE PATIENT INDICATED A PROBLEM WITH THE LEADS. THE HEALTH CARE PROVIDER HAD SAID SOMETHING ABOUT ONE OF THE LEADS BEING LOOSE OR SOMETHING, BUT IT WAS NOT A DEFECT OF THE LEAD (IT WAS JUST OLD AND NEEDED TO BE REPLACED). THE PATIENT THOUGHT THAT THE HEALTH CARE PROVIDER DISCOVERED THE PROBLEM WITH THE LEAD DURING THE REPLACEMENT PROCEDURE, AND AFTER HE SAID THAT ONE WAS A LITTLE LOOSE OR NOT DOING ITS JOB. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. THE PATIENT¿S MEDICAL HISTORY INCLUDES HAVING PREVIOUS MRI¿S DUE TO SHOULDER PROBLEMS AND ISSUES UNRELATED TO THE SPINAL CORD STIMULATION DEVICE OR THERAPY. THE PATIENT ALSO HAD AN UNRELATED INNER EAR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324454 1X8 SUBCOMPACT LEAD STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 377645 V008187

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention