BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1844845 · Received September 23, 2010

    Report

    Report Number
    3004209178-2010-07231
    Event Type
    Malfunction
    Date Received
    September 23, 2010
    Date of Event
    February 15, 2010
    Report Date
    August 23, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - WRENCH. FINAL DEVICE ANALYSIS REVEALED A RELIABILITY NON-CONFORMANCE; THE INS CONNECTOR PORT HAD A LEAD INSERTION ANOMALY. A KNOWN GOOD LEAD HAD DIFFICULTY AT THE #2 BALSEAL BUT STILL WENT THROUGH. THE LEAD WOULD NOT PASS THROUGH THE #4 BALSEAL CONNECTOR. IT APPEARED ON X-RAY THAT THE BALSEAL SPRING WAS DEFORMED. THERE WAS NO DIFFICULTY INSERTING THE LEAD INTO THE #8-15 CONNECTOR PORT. ANALYSIS OF THE WRENCH REVEALED NO ANOMALIES.

    Description of Event or Problem · 1

    DURING IMPLANT, IT WAS NOT POSSIBLE TO INSERT THE EXTENSION INTO THE INS DESPITE MULTIPLE ATTEMPTS. A NEW INS WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE PRIME ADVANCED LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37702 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention UNK CONVERSION TYPE: MODEL WRENCHN, LOT# UNK| EXTENSION: MODEL 37081, LOT# NJB070662V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB070173V| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 39565-30, LOT# N200499003| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE143152N