BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 5773359 · Received July 6, 2016

    Report

    Report Number
    3004209178-2016-13627
    Event Type
    Injury
    Date Received
    July 6, 2016
    Date of Event
    June 15, 2016
    Report Date
    August 5, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3888-45, LOT# V612850, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID 3888-45, LOT# V851631, IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. THE HEALTHCARE PROFESSIONAL REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT A PATIENT IMPLANTED FOR SPINAL PAIN AND COMPLEX REGIONAL PAIN SYNDROME HAD LEADS THAT ERODED THROUGH THE SKIN. THE STIMULATOR REMAINED IMPLANTED AND THE LEADS WERE TO BE RE-IMPLANTED IN FIVE WEEKS. 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

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE DIAGNOSIS WAS HIGH IMPEDANCE. THE CLINICAL DIAGNOSIS WAS A LOSS OF THERAPEUTIC RELIEF. THERE WAS LEAD MIGRATION/DISLODGEMENT. THERE WAS LEAD EROSION THROUGH SCROTAL SAC SKIN. INTERVENTIONS INCLUDED REPROGRAMMING. INTERVENTIONS INCLUDED EXPLANTING AND NOT REPLACING THE LEADS. THE EVENT RESULTED IN AN UNSCHEDULED CLINIC OR OFFICE VISIT. THE PATIENT REPORTED A LOSS OF PAIN CONTROL. THE DEVICE WAS INTERROGATED AND SHOWED THAT IMPEDANCES WERE OUT OF RANGE. THE LEAD WAS PROTRUDING FROM THE SITE. AN EXAMINATION SHOWED LEAD EROSION THROUGH SCROTAL SAC SKIN. THE ETIOLOGY WAS REPORTED AS RELATED TO THE DEVICE OR THERAPY AND NOT RELATED TO THE IMPLANT PROCEDURE. THE ETIOLOGY WAS REPORTED AS RELATED TO THE LEADS WHICH WERE CONNECTED TO THE IMPLANTABLE NEUROSTIMULATOR (INS). THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE. IT WAS UNKNOWN WHICH LEAD ERODED THROUGH THE SKIN.

    Description of Event or Problem · 1

    THE HEALTHCARE PROFESSIONAL REPORTED VIA THE MANUFACTURER REPRESENTATIVE THAT A PATIENT IMPLANTED FOR SPINAL PAIN AND COMPLEX REGIONAL PAIN SYNDROME HAD LEADS THAT ERODED THROUGH THE SKIN. THE STIMULATOR REMAINED IMPLANTED AND THE LEADS WERE TO BE RE-IMPLANTED IN FIVE WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427494 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention