BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 2760148 · Received September 26, 2012

    Report

    Report Number
    3004209178-2012-08524
    Event Type
    Injury
    Date Received
    September 26, 2012
    Report Date
    August 28, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748910 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID, 748910 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID, 7435 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 389045 LOT# J0527050V SERIAL#, IMPLANTED: 2005 (B)(6), EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID, 389045 LOT# J0537641V SERIAL#, IMPLANTED: 2005 (B)(6), EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AN INFECTION FOLLOWING HIS 2005 IMPLANT. HE CONTRACTED (B)(6) WHILE AT THE MEDICAL CENTER. THE PATIENT WAS SENT HOME WITH A PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE FOR 7 WEEKS WHILE ON VACAMYTHISON 2X PER DAY. AFTER TWO MONTHS THE INFECTION CLEARED. IT WAS NOTED THAT THE PATIENT HAD 2 "FLAIR UP" INFECTIONS THAT OCCURRED IN 2006 AND 2007 BUT WAS NOT BELIEVED TO BE RELATED TO THE IMPLANT BECAUSE, THE INFECTIONS OCCURRED AT HIS WAISTLINE AND NOT THE IMPLANT SITE. CULTURES WERE PERFORMED OF THE INFECTION. IT WAS ALSO STATED THAT THE PATIENT WAS ON A PAIN PATCH BECAUSE HE HAD SEVEN HERNIATED DISKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention