BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 4192985 · Received October 22, 2014

    Report

    Report Number
    3004209178-2014-20171
    Event Type
    Injury
    Date Received
    October 22, 2014
    Report Date
    October 1, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD PAIN AROUND THE IMPLANT AND THAT THE MRI WAS TO SCAN THE LUMBAR REGION. THE AREA TO BE SCANNED WAS THE I-SPINE. ¿RELATED TO DEVICE OR THERAPY, RULE OUT POSSIBLE INFECTION AT SITE¿. A POSSIBLE INFECTION WAS REPORTED. 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 MOVEMENT THAT WAS REPORTED EARLIER WAS REFERRING TO THE POCKET REVISION. THE PATIENT WAS DOING REALLY WELL THE LAST TIME THE MANUFACTURER¿S REPRESENTATIVE (REP) SPOKE TO THE DOCTOR ON (B)(6) 2014 FOLLOWING THE POCKET REVISION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS IMPLANTABLE NEUROSTIMULATOR (INS) MOVEMENT. THE PATIENT COMPLAINED OF EXCESSIVE PAIN AND A BURNING SENSATION AT THE RIGHT SIDE IMPLANT POCKET. A POCKET REVISION WAS PERFORMED, AND THE INS WAS MOVED APPROXIMATELY 6 INCHES TO THE RIGHT. THIS WAS SAID TO BE SUCCESSFUL, AND THE PATIENT¿S PAIN RESOLVED. THE CAUSE OF THE EVENT WAS NOT DETERMINED, AND NO DEVICE ISSUES OR MALFUNCTIONS WERE OBSERVED. THE WAS NO DETERMINATION MADE REGARDING THE POSSIBLE INFECTION, THOUGH THE REVISION RESOLVED THE EVENT AND THE PATIENT WAS RECEIVING EFFECTIVE THERAPY. IT WAS UNCLEAR IF THE ¿INS MOVEMENT¿ REFERRED ONLY TO THE REVISION SURGERY, OR IF THE DEVICE WAS MOVING IN THE POCKET. FOLLOW-UP IS BEING CONDUCTED FOR CLARIFICATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671289 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention