BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1708970 · Received June 1, 2010

    Report

    Report Number
    3004209178-2010-04368
    Event Type
    Malfunction
    Date Received
    June 1, 2010
    Date of Event
    April 20, 2010
    Report Date
    April 20, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT REPORTED NO STIMULATION AT 1.2 V. THERE WAS A PROBLEM WITH THE IMPLANTABLE NEUROSTIMULATOR (INS). AN END OF SERVICE/END OF LIFE MESSAGE WAS NOTED. EOL WAS SEEN ON THE CLINICIAN PROGRAMMER. THE BATTERY WAS MEASURED TWO MORE TIMES AND THE EOL MESSAGE REMAINED WITH A BATTERY MEASUREMENT OF 2.11 V AND 92-100% FOR CAPACITY. THE THERAPY IMPEDANCE READ 965 AND 1163. THE ELECTRODE IMPEDANCES AT 2.0 V AND 450 PW READ 1023-1375. ELECTRODE IMPEDANCES AT 4.0 V 450 PW READ 813-1378. WHEN THE INS WAS TURNED OFF, THE PT DID NOT FEEL PARESTHESIA. THE LIGHTNING BOLT WAS SEEN ON THE CLINICIAN PROGRAMMER TO INDICATE THAT STIMULATION WAS ON. THE PT HAD NOT HAD ANY RECENT MEDICAL PROCEDURES OTHER THAN A COLONOSCOPY AND ENDOSCOPY, BUT NO CAUTERY USED. IT WAS NOTED THAT THE PT HAD A FALL AND FELL ON THEIR BACK, BUT THE INS WAS IMPLANTED IN THE LEFT ABDOMEN AND THE PT HAD STIMULATION AFTER THE FALL. A LONGEVITY ESTIMATE WAS PERFORMED, USED THE CURRENT DEVICE PROGRAMMING OF 1.2 V, 210 PW AND 30 RATE WITH AN UPPER LIMIT OF 2 FOR BOTH PROGRAMS. THE PT PROGRAMMER WAS COMMUNICATING WITH THE INS FINE. NO POWER-ON-RESET WAS SEEN. THE DEVICE WAS REPROGRAMMED AT 6 V AND THE PT REPORTED PARESTHESIA. ADDITIONAL INFO RECEIVED REPORTED THAT THE INS WAS BEING REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR PROGRAMMER: MODEL 7435, LOT# NFT020000P| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK011533V| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495LZ, LOT# NHK011532V| LEAD: MODEL 3487A, LOT# J0211556V| LEAD: MODEL 3487A, LOT# J0211556V