BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 3970161 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13734
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 17, 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
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 39565-65, SERIAL # (B)(4), IMPLANTED: (B)(4) 2014, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S POCKET WAS SWOLLEN AND THE PATIENT HAD COMMUNICATION/TELEMETRY AND COUPLING ISSUES. IT WAS NOTED THAT MEDICAL INTERVENTION WAS NEEDED AND THE POCKET WAS ASPIRATED. IT WAS FURTHER NOTED THAT IMPEDANCE TESTING AND REPROGRAMMING WAS DONE. THE REPORTER STATED THAT THERE WAS FLUID IN THE POCKET THAT IMPEDED COMMUNICATION WITH THE PATIENT PROGRAMMER AND COUPLING WITH THE RECHARGER. THE REPORTER FURTHER STATED THE PATIENT WAS HAVING A DIFFICULT TIME CHARGING DUE TO SWELLING IN THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET. IT WAS NOTED THAT THE CHARGING LOG CONFIRMED AN AVERAGE OF FOUR COUPLING BARS FOR THE LAST FEW RECHARGES. IT WAS FURTHER NOTED THE PATIENT¿S HEALTHCARE PROFESSIONAL ASPIRATED THE INS POCKET AND 20 ML OF BLOODY FLUID WAS ASPIRATED. THE REPORTER STATED THE PATIENT WAS THEN ABLE TO GET EIGHT COUPLING BARS WITHOUT ISSUE. IT WAS NOTED THE PATIENT HAD PAIN AT THE IMPLANT SITE. IT WAS FURTHER NOTED THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS ALIVE WITH NO INJURY. IT WAS NOTED THE PATIENT WAS FEELING MUCH BETTER AND THEIR COVERAGE WAS VERY GOOD. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT STARTED HAVING COUPLING AND RECHARGING ISSUES SINCE THEIR INS POCKET REVISION ON (B)(6) 2014. 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
    446670 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention