BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDEAVOR SPRINT RX

    MDR report key: 1040076 · Received May 7, 2008

    Report

    Report Number
    2953200-2008-00288
    Event Type
    Injury
    Date Received
    May 7, 2008
    Date of Event
    March 20, 2008
    Report Date
    April 7, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P060033
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: MYOCARDIAL INFARCTION. LACK OF INFO. CONCLUSIONS: LACK OF INFO.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE TWO LESIONS TREATED WITH TWO ENDEAVOR STENT (3.0 X 24 MM STENTS) REF MDR 2953738-2001-00289 APPROXIMATELY ONE MONTH AGO. BOTH LESION WERE LOCATED IN THE PROXIMAL LAD (OVERLAPPING STENTS). ON THE SAME DAY AS STENT IMPLANT, THE PT SUFFERED AN ACUTE NON-STEMI. IT WAS REPORTED THAT THE PT HAD CHEST PAIN DURING THE PCI PROCEDURE. THE LOCATION OF THE INFARCT IS NON-DETERMINABLE. IT IS UNK WHETHER THE TARGET LESION WAS INVOLVED. THE INVESTIGATOR ASSESSED THE EVENT AS A NON Q-WAVE MI AND DID NOT PROVIDE AN OPINION REGARDING THE RELATIONSHIP OF THE EVENT TO THE PRODUCT. PLEASE NOTE THAT THIS MODEL NUMBER IS NOT DISTRIBUTED IN THE UNITED STATES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDEAVOR SPRINT RX NIQ MEDTRONIC CARDIOVASCULAR GALWAY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK