BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME ADVANCED

    MDR report key: 2250647 · Received September 9, 2011

    Report

    Report Number
    3004209178-2011-07646
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED EXTREME PAIN AFTER THE SURGERY TO IMPLANT HER IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THE HEALTH CARE PROVIDER (HCP) BROUGHT HER BACK INTO SURGERY TO MOVE THE LEAD OFF HER SPINE AND LEFT THE COMPONENTS IN PLACE UNDER THE SKIN AND NOT IN THE EPIDURAL SPACE. F/U INFO INDICATED THAT THERE WAS NO KNOWN CAUSE FOR THE PT'S PAIN AND THAT SHE DID NOT HAVE A HEMATOMA. THE HCP BELIEVED THAT THE PAIN THAT THE PT WAS FEELING WAS SURGICAL-RELATED TO POSITION OF THE LEAD. THE PT ALSO REPORTED THAT SHE DIDN'T RECEIVE A PT PROGRAMMER FOR HER INS AND THAT IT WAS NOT HOOKED UP. SHE REQUESTED THAT HER INS BE EXPLANTED DUE TO CONTINUED PAIN ISSUES. THE HCP WAS TRYING TO WORK WITH THE PT TO MOVE THE LEAD BACK INTO A PLACE TO RESTORE THERAPY INSTEAD OF EXPLANTING THE ENTIRE SYSTEM. THE PT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A F/U REPORT WILL BE SENT IF INFO BECOMES AVAILABLE.

    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 56 YR Required Intervention EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE169906N| IMPLANTED:| LEAD: MODEL 39565-65, LOT# V548214020