BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN STARFIX

    MDR report key: 3991037 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-08359
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 27, 2014
    Report Date
    May 19, 2014
    Manufacturer
    MPRI
    Product Code
    OJX
    PMA / PMN Number
    P060039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: A 5076-52 LEAD, IMPLANTED: (B)(6) 2005. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POCKET STIMULATION AND CAN VISIBLY SEE THE DEVICE INTERMITTENTLY BOUNCING IN THE CHEST. THE PATIENT ALSO MENTIONS THAT THE LEFT ARM MOVES WITH HEART BEATS AS WELL. THE PATIENT THOUGHT THAT A LEAD HAD FRACTURED BUT LEAD TESTING FOUND THAT THE LEFT VENTRICULAR (LV) LEAD WAS CAUSING POCKET STIM. THE LV LEAD WAS CAPPED AND NOT REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469252 ATTAIN STARFIX DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MPRI 419588

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| R D314TRM ICD, 6935M62 LEAD