BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 1841862 · Received September 21, 2010

    Report

    Report Number
    3004209178-2010-07127
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 27, 2010
    Report Date
    August 27, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    DURING PUMP REPLACEMENT SURGERY (SEE MFR'S REPORT # 3004209178201007125), THE PHYSICIAN DID NOT LIKE THE SECURITY OF THE CONNECTION OF A PUMP CONNECTOR. HE FELT THAT THE PUMP CONNECTOR ON PRODUCTS 8907 AND 8590-9 DID NOT SECURE THE PUMP TO THE CATHETER AS WELL AS THE SUTURELESS CONNECTORS. THE PHYSICIAN USED THE 8575 INSTEAD. THERE WAS NO PT INJURY. THE PT RECOVERED WITHOUT SEQUELA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED II LKK MDT PUERTO RICO OPERATIONS CO., JUNCOS 8637-20 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR EXPLANTED:| CATHETER: MODEL 8709, LOT# N260005012| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| UNK CONVERSION TYPE: MODEL 8590-9, LOT# N254967| EXPLANTED:| CATHETER: MODEL 8578, LOT# N261139001| EXPLANTED:| CATHETER: MODEL 8709SC, LOT# N184296003| IMPLANTED:| IMPLANTABLE INFUSION PUMP: MODEL 8637-20| IMPLANTED:| LOT# NGP329402H