BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4475754 · Received February 2, 2015

    Report

    Report Number
    3004209178-2015-01589
    Event Type
    Injury
    Date Received
    February 2, 2015
    Report Date
    January 13, 2015
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3487A, LOT# L36987, IMPLANTED: (B)(6) 1996, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1996, PRODUCT TYPE: EXTENSION; PRODUCT ID 3550-09, LOT# LB6351, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3487A, LOT # L36987, IMPLANTED: (B)(6) 1996, EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD; PRODUCT ID 7495-51, SERIAL # (B)(4), IMPLANTED: (B)(6) 1996, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-09, LOT # LB6351, IMPLANTED: (B)(6) 2003, PRODUCT TYPE ACCESSORY; PRODUCT ID 3487A, LOT # L36987, IMPLANTED: (B)(6) 1996, EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD. ANALYSIS OF THE INS (S/N (B)(4)) FOUND NO SIGNIFICANT ANOMALY. THE INS BATTERY WAS NOT IN NEW CONDITION. ANALYSIS OF THE LEAD (L/N L36987) FOUND ALL OF THE LEAD BODY¿S CONDUCTORS WERE BROKEN AT AN UNKNOWN ANCHOR SITE. THE LEAD BODY¿S OUTER INSULATION WAS BREACHED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S BATTERY DEPLETION WAS NOT NORMAL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE STIMULATOR WAS TURNED AND CURRENTLY PROGRAMMED AS 012+-+. THE PATIENT WAS SET TO 10.5 VOLTS, 450 MICROSECONDS, AND 80 HERTZ AND WAS FEELING NOTHING. THE THERAPY MEASUREMENT WAS 1137 OHMS. ON (B)(6) THINGS WERE FINE, AND THEN ON THE (B)(6) THE PATIENT FELT A ZING SENSATION AND HADN¿T FELT STIMULATION SINCE. THERE WERE NO FALLS OR ACCIDENTS. ELECTRODE IMPEDANCES WERE 03: GREATER THAN 4,000, 13:???, 23: 1395, 01: 1395, 02: 1395, AND 12: 1395. IT WAS RUN AGAIN AT 3.0 VOLTS AND 450 MICROSECONDS AND WAS AS FOLLOWS: 01:???, 02: 2012, 03: 3030, 12: 1502, 13: 2983, AND 23: 1991. REPROGRAMMING WAS TRIED WITH THE CATHODE ON EACH CONTACT WITH NO STIMULATION RESPONSE. PALPATION WAS ALSO TRIED WITH NO RESPONSE ELICITED. THE BATTERY VOLTAGE WAS GOOD AT 2.6 AND SAID 40-80% USED. THE MANUFACTURER¿S REPRESENTATIVE (REP) CALLED BACK IN TO ASK LONGEVITY ESTIMATES AT 3.1 VOLTS, 300 MICROSECONDS, 80 HERTZ. THERE WERE THREE ACTIVE ELECTRODES AND 1137 OHMS. THE HOURS/DAY USAGE WAS 12. FOR A PRIMARY CELL DEVICE IT WAS 89 MONTHS. FOR A RECHARGEABLE IT WAS 45 DAYS FOR RECHARGE INTERVAL. THE REP. FURTHER REPORTED THAT THE CAUSE OF THE EVENT WAS NOT DETERMINED AND IT WAS UNKNOWN IF IT WAS DEVICE RELATED. REPROGRAMMING WAS UNABLE TO BE PERFORMED. THE PATIENT DIDN¿T FEEL STIMULATION TO 10.5 VOLTS WITH ANY ELECTRODE COMBINATION. A FULL SYSTEM CHANGE WAS SCHEDULED FOR JANUARY 26, 2015. THE PATIENT WASN¿T CURRENTLY RECEIVING EFFECTIVE THERAPY. THE REP. LATER REPORTED THAT A FULL CHANGE OCCURRED ON (B)(6). THE PATIENT WAS DOING WELL AND RECEIVING EFFECTIVE THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    76191 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention