BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 1822427 · Received August 26, 2010

    Report

    Report Number
    3004209178-2010-06459
    Event Type
    Injury
    Date Received
    August 26, 2010
    Date of Event
    July 29, 2010
    Report Date
    July 29, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN IDENTIFIED A POTENTIAL FRACTURE IN EITHER THE EXTENSION OR LEAD. TESTING AND INTRA-OPERATIVE IMPEDANCES SHOWED THE LEAD DID HAVE SOME HIGH IMPEDANCES WHICH WERE PREVENTING THERAPY. THE EXTENSION WAS REPLACED. AFTER REPLACEMENT, NO MALFUNCTIONS OR LOSS OF STIMULATION WAS NOTED. NO PT INJURIES WERE REPORTED AND THEY RECOVERED WITHOUT SEQUELAE.

    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 Required Intervention IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC016586N| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC016585N| EXPLANTED:| LEAD: MODEL 3986A, LOT# N0025549| EXPLANTED:| LEAD: MODEL 3986A, LOT# N0025766| EXPLANTED: