BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3812289 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09016
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Report Date
    April 21, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(4) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S SWELLING HAD RESOLVED. IT WAS NOTED THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS POSITIONED FINE FOR THE PATIENT TO RECEIVE THERAPEUTIC EFFECT. IT WAS FURTHER NOTED THE PATIENT WAS REPROGRAMMED. THE REPORTER STATED THEY HAD NOT HEARD FROM THE PATIENT SINCE THE LAST VISIT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE REPORTER STATED THAT THEIR THERAPY HAD NOT BEEN WORKING LIKE IT WAS AT FIRST FOR THE PAST THREE WEEKS. THE REPORTER FURTHER STATED THEY WERE ADVISED TO SET UP AN APPOINTMENT FOR AFTER THE SWELLING WENT DOWN. IT WAS NOTED THE IMPLANTABLE NEUROSTIMULATOR (INS) SETTLED LOWER THAN IT WAS BECAUSE OF THE FLUIDS AND SWELLING. IT WAS FURTHER NOTED THE PATIENT WAS TOLD BY THEIR HEALTHCARE PROFESSIONAL TO SCHEDULE AN APPOINTMENT WITH A MANUFACTURING REPRESENTATIVE DIRECTLY THROUGH THE MANUFACTURER. IT WAS NOTED THE PATIENT WANTED HELP WITH REPROGRAMMING. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT RECEIVED ASSISTANCE FROM A MANUFACTURING REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED. IT WAS NOTED THE PATIENT HAD AN APPOINTMENT ON 2014-04-23. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290106 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR