BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4781832 · Received May 19, 2015

    Report

    Report Number
    3004209178-2015-09379
    Event Type
    Injury
    Date Received
    May 19, 2015
    Report Date
    September 2, 2016
    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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID; 97740, LOT# SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39565-65, LOT# SERIAL# (B)(4) IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).

    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

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT WHEN SHE GOT THE DEVICE THEY TRIED TO PROGRAM THE DEVICE BACK IN 2015 TO CAPTURE PAIN IN HER RIGHT LEG, BUT THEY "COULDN'T REALLY." THEN THE PAIN STOPPED AND NOW IT WAS BACK AND CONSTANT. SHE NEEDED TO MAKE AN APPOINTMENT TO MEET WITH A REPRESENTATIVE TO HAVE HER DEVICE PROGRAMMED TO ADDRESS THIS BREAK OUT PAIN IN HER RIGHT LEG. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER NOTED HAVING A DOCTOR'S APPOINTMENT BOTH IN (B)(6) OF 2015, AND A DOCTOR'S APPOINTMENT ON (B)(6) 2016. THE CIRCUMSTANCES THAT LED TO THE EVENT WERE NOTED AS "NOTHING-TRANSIENT PAIN." STEPS TAKEN TO RESOLVE THE INCREASE IN PAIN WERE NOTED AS "PROGRAMMING CHANGE X2 IN 2015 - UNSUCCESSFUL."

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT DID HAVE A REVISION PROCEDURE ON (B)(6) 2015 OF THE LEADS AND STIMULATOR. THE REVISION WAS DUE TO THE STIMULATION NOT COVERING THE PAIN AREA. ON (B)(6) 2015 IT WAS NOTED THAT PROGRAMMING WAS ATTEMPTED ON (B)(6) 2015 WITHOUT SUCCESS, PRIOR TO THE IMPLANT. THE IMPEDANCE CHECK WAS PERFORMED AND ALL ELECTRODES WERE WITHIN RAGE. THE PATIENT WAS TO BE SEEN FOR FURTHER FOLLOW-UP ON (B)(6) 2015. ON (B)(6) 2015 IT WAS NOTED THAT THE PATIENT MET WITH THE MANUFACTURER REPRESENTATIVE FOR ACTIVATION OF HER NEW DEVICE AND WAS NOTING THAT THE THERAPY WAS COVERING ALL OF HER PAIN AREAS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE LEADS WERE REPLACED; THE PATIENT WAS IMPLANTED WITH A NEW RECHARGEABLE DEVICE, PADDLE AND LEADS. THE HEALTHCARE PROFESSIONAL DETERMINED THAT THE LEADS MAY BE CAUSING THE ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    325107 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97702

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention