BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4898518 · Received July 8, 2015

    Report

    Report Number
    3004209178-2015-12942
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Date of Event
    June 10, 2015
    Report Date
    December 8, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DATE WAS UPDATED TO REFLECT THE CORRECT NOTIFY DATE OF WHEN THE FIRST MANUFACTURER¿S REPRESENTATIVE (REP) BECAME AWARE OF REPORTABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377760, LOT# V014129, IMPLANTED:(B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT# V014129, IMPLANTED:(B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED:(B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED:(B)(6) 2006, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN, PRODUCT TYPE: UNKNOWN. PRODUCT ID: NEU_UNKNOWN, PRODUCT TYPE: UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S LEADS WERE FRACTURED. THE FRACTURES WERE DISCOVERED AT THE TIME OF HER REPLACEMENT IMPLANT PROCEDURE ON (B)(6) 2014, BUT THE LEADS WERE NOT REPLACED. THE PATIENT STATED SHE WAS EXPERIENCING PAIN AT THE SITE OF THE ANCHORS AND THE AREA HAD BEEN CONCAVE BUT NOW IT WAS PUSHED OUT AND TENDER ON THE DAY OF REPLACEMENT, AND THE PATIENT WANTED TO KNOW WHAT MANUFACTURER¿S REPRESENTATIVE (REP) WAS PRESENT AT THEIR SURGERY. IT WAS NOTED THE PATIENT HAD NOT BEEN SEEN AT THEIR HEALTHCARE PROVIDER¿S OFFICE IN OVER A YEAR AS OF (B)(6) 2015. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER'S REPRESENTATIVE (REP) WAS AWARE AT THE TIME OF SURGERY THAT THE LEAD IMPEDANCE WAS SLIGHTLY HIGH AT THAT TIME BUT THERE WERE NO LEAD FRACTURES THEY WERE AWARE OF. THE REP. WAS ALSO NOT AWARE OF THE COMPLAINT REGARDING THE ANCHORS. POST REPLACEMENT THE PATIENT WAS GETTING EFFECTIVE STIMULATION. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED AT THAT TIME DUE TO NORMAL BATTERY REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442041 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR