BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 3830335 · Received May 23, 2014

    Report

    Report Number
    3004209178-2014-09566
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Report Date
    May 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
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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: 2013 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: 2013 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT CAME INTO THE DOCTOR¿S OFFICE COMPLAINING OF THE INABILITY TO COMMUNICATE WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) WITH EITHER THE PATIENT PROGRAMMER OR THE RECHARGER. IT WAS DETERMINED BY THE DOCTOR AND THE CLINICAL SPECIALIST THAT THE INS MAY HAVE FLIPPED. IT WAS NOTED THAT THE FLIP WAS NOT CONFIRMED. IT WAS NOTED THAT THE PATIENT PROGRAMMER, PATIENT CHARGER AND CLINICIAN PROGRAMMER WERE TRIED AND NOTHING WOULD COMMUNICATE WITH THE INS. THE PATIENT HAD BRUISING OVER THE AREA OF THE INS BUT DENIED AND RECENT TRAUMA TO THE AREA. THE DOCTOR GAVE THE PATIENT THE OPTION TO HAVE SURGERY TO OPEN UP THE INS POCKET AND LOOK AT THE BATTERY AND PLACE BACK INTO THE CORRECT POSITION OR CHANGE OUT THE BATTERY FOR A NEW ONE OR WAIT AND DO NOTHING. AT THE TIME OF THIS REPORT THE PATIENT HAD DECIDED TO WAIT AND SEE. THE PATIENT NOTED THAT THEY COULD ¿ALWAYS FEEL THE TINGLES AND THAT THEY DEALT GOOD¿ BUT THEY NEVER RELIEVED THE PAIN. BECAUSE OF THAT THE PATIENT HAD DECIDED TO WAIT TO MAKE THEIR DECISION. SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT INCLUDED LESS THAN 50% THERAPY RELIEF AT THE RIGHT SIDE IMPLANT. IT WAS NOTED THAT THERE WAS A COMPLETE LOSS OF THERAPY. THE EVENT OCCURRED DURING NORMAL USE. IT WAS NOTED THAT THERE WAS A COMMUNICATION/TELEMETRY ISSUE DESCRIBED AS A COUPLING ISSUE. DIAGNOSTIC TESTING OR TROUBLESHOOTING INCLUDED IMPEDANCE TESTING AND REPROGRAMMING. THE ISSUE WAS NOT RESOLVED. THE CAUSE OF ISSUE WAS NOT DETERMINED. THE PRODUCT STATUS OF THE INS WAS IMPLANTED AND OUT OF SERVICE. THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE MANUFACTURING REPRESENTATIVE AND HEALTHCARE PROFESSIONAL (HCP) COULD NOT COME UP WITH A REASON FOR A FLIPPED DEVICE. THE REPORTER STATED THE HCP TRIED TO MANUALLY FLIP THE DEVICE BACK TO THE ORIGINAL POSITION, BUT THEY WERE UNSUCCESSFUL. IT WAS NOTED THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY AT THIS TIME. IT WAS FURTHER NOTED THE PATIENT'S BATTERY WAS AT ZERO AT THE TIME OF THE INCIDENT. THE REPORTER STATED THE PATIENT DID NOT THINK IT WAS GIVING THEM ADEQUATE PAIN RELIEF EVEN THOUGH THEY FELT TINGLES IN THE CORRECT PLACES WHEN THE DEVICE WAS CHARGED AND WORKING CORRECTLY. THE REPORTER FURTHER STATED THE PATIENT DECIDED TO WAIT AND SEE IF THEY WANTED TO GO THROUGH SURGERY AGAIN SINCE THE DEVICE WAS NOT REALLY HELPING. IT WAS NOTED THAT NO INTERVENTIONS WERE PLANNED AT THIS TIME. THE REPORTER STATED THEY WERE WAITING TO HEAR WHAT THE PATIENT WOULD LIKE TO DO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307735 SURESCAN STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 97714

    Patients

    Seq Age Sex Outcome Treatment
    1