BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY PLUS

    MDR report key: 2473878 · Received March 1, 2012

    Report

    Report Number
    3004209178-2012-01277
    Event Type
    Injury
    Date Received
    March 1, 2012
    Report Date
    February 10, 2020
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 399930, LOT # V002263, EXTENSION MODEL 748940, SERIAL # (B)(4), EXTENSION MODEL 748940, SERIAL # (B)(4), PROGRAMMER MODEL 7439, SERIAL # (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID: 399930, LOT# V002263, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD; PRODUCT ID: 748940, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID: 7439, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING THEIR DEVICE REMOVED BECAUSE IT WAS UNCOMFORTABLE. AT THE TIME OF REPORT, THE PATIENT WAS NOT PLANNING ON HAVING ANOTHER DEVICE IMPLANTED, AND WAS PLANNING TO LEAVE THE LEADS AND EXTENSIONS INTERNALIZED. NO PATIENT OUTCOME WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) INDICATING THAT THEIR INITIAL INS WAS REMOVED DUE TO NORMAL BATTERY DEPLETION AND WAS REPLACED IN 2012. THE PATIENT ALSO INDICATED THAT WHEN THEIR INS WAS REPLACED IN 2012, THEY DID NOT REMOVED THEIR ¿INS¿ (INFORMATION SUGGESTS THIS MEANT TO READ LEADS/EXTENSION AS REPORTED PREVIOUSLY). NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY PLUS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7479

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention