BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4223848 · Received November 4, 2014

    Report

    Report Number
    3007566237-2014-03220
    Event Type
    Malfunction
    Date Received
    November 4, 2014
    Date of Event
    October 26, 2010
    Report Date
    October 10, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    (B)(6) 2014, (B)(6), THE PATIENT WAS NOT ABLE TO GET A BOLUS. THE PATIENT GETS 6 BOLUSES IN 24 HRS, AND THEIR LOCKOUT INTERVAL IS 2 HRS. THE PATIENT TRIED GIVING HIMSELF A BOLUS AT 8 AM THE MORNING OF THE REPORT AND THE PTM SHOWED TO WAIT FOR 2 HRS. THE PATIENT HAD STATED HE ONLY USED 4 BOLUSES AT THAT TIME. THE PATIENT WAS ABLE TO GET A BOLUS AT 10:01 AM. THE PATIENT THEN TRIED TO GET A BOLUS AT 2 PM AND PTM SHOWED TO WAIT 2 HRS. THE PTM ALWAYS SHOWED TO WAIT FOR 2 HRS WHEN THE PATIENT GETS DENIED. THE PATIENT STATED THAT THEY HAD THIS ISSUE SINCE THEY GOT THE PTM (GOT PTM WHEN IMPLANTED ON (B)(6) 2010) BUT IT HAPPENED RARELY. THE WEEK OF THE REPORT, THE PROBLEM GOT ¿REALLY BAD¿. PER THE PATIENT, EVEN WITH THEIR ¿NEW PTM AND ANTENNA¿, THE PROBLEM HAD NOT RESOLVED. THE PATIENT STATED IT ¿MUST BE THE PUMP ITSELF¿. THE PATIENT WAS NOT SEEING THE COMMUNICATION UNSUCCESSFUL SCREEN BUT DID SEE THAT SCREEN BEFORE BUT THAT WAS NOT HAPPENING NOW. THE PATIENT WILL TRY PTM ANTENNA. THE PUMP WAS USED TO DELIVER FENTANYL AND BUPIVACAINE. INTERVENTIONS, SYMPTOMS OR PATIENT OUTCOME NOT REPORTED. FURTHER FOLLOW-UP WAS BEING CONDUCTED TO OBTAIN INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705434 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MEDTRONIC NEUROMODULATION 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00028 YR