BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2181253 · Received July 22, 2011

    Report

    Report Number
    3004209178-2011-05661
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS EXPLANTED ON (B)(6) 2011. THE SURGICAL LEAD WAS LEFT IN PLACE AND LEADS WERE USED AS PLUGS FOR THE WIRES. THE ANALYSIS DETERMINED THAT THERE WAS NO INFECTION BUT PERHAPS AN ALLERGY OR POCKET PAIN. THE SYMPTOMS WERE PAIN, REDNESS AROUND THE POCKET AREA. THE PT WILL BE REIMPLANTED WITH ANOTHER DEVICE. THE PT OUTCOME AND CURRENT STATUS WAS "RECOVERING." ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    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 77 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE161777N| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 39565-65, LOT # V531206006