BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURESCAN

    MDR report key: 6223945 · Received January 4, 2017

    Report

    Report Number
    3004209178-2017-00243
    Event Type
    Injury
    Date Received
    January 4, 2017
    Date of Event
    January 1, 2017
    Report Date
    February 20, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER NO LONGER APPLIES. UPON FURTHER REVIEW, SECTION E WAS CORRECTED. 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

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT. IT WAS REPORTED THAT THE PATIENT WAS CURRENTLY IN REHAB BECAUSE THEY STARTED FALLING A LOT AND HAD GONE INTO THE HOSPITAL A COUPLE OF TIMES. THE CONSUMER STATED THAT THE PATIENT NEEDED TO HAVE THEIR DEVICE REPROGRAMMED AND RECHARGED, AS WELL AS EDUCATION ON HOW TO USE THE EXTERNAL EQUIPMENT. IT WAS REPORTED THAT THE PATIENT WAS IN TREMENDOUS AMOUNT OF PAIN. IT WAS NOTED THAT THE FALLING ISSUE SEEMED TO HAVE STARTED AFTER THE PATIENT WAS IMPLANTED ON (B)(6) 2016. THE CONSUMER STATED THAT THEY WEREN¿T SURE, BUT THE PATIENT HAD NEVER REALLY FALLEN LIKE THEY HAVE SINCE GETTING THE IMPLANT. IT WAS ALSO MENTIONED THAT THE PATIENT HAD A URINARY TRACT INFECTION (UTI) AND THAT SOMETIMES IT COULD MAKE THE LEGS WEAK. THE PATIENT WAS TO FOLLOW UP WITH THEIR HEALTHCARE PROVIDER (HCP) AND REQUEST A MANUFACTURER REPRESENTATIVE TO BE PRESENT AS WELL. INDICATION FOR USE IS NON-MALIGNANT PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HCP. IT WAS REPORTED THAT THE PATIENT FIRST STARTED EXPERIENCING THE UTI ON (B)(6) 2017. PRIMARY CARE PHYSICIAN, HOME CARE, ANTIBIOTICS, AND NURSING HOME WERE NOTED AS ACTIONS/INTERVENTIONS TAKEN TO RESOLVE THE FALLS, PAIN, AND UTI. THE FALLS, PAIN, AND UTI HAD BEEN RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4221 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other| R