BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 3894157 · Received June 25, 2014

    Report

    Report Number
    3004209178-2014-12025
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    June 3, 2014
    Report Date
    June 4, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6);: PRODUCT TYPE EXTENSION PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A POSSIBLE INFECTION AS THE ROUTINE FOLLOW UP NOTES THE IMPLANTABLE NEUROSTIMULATOR (INS) BATTERY SITE WAS RED AND INDURATED. AN ACTION OF A SURGICAL CONSULT WAS TO OCCUR IN THE MORNING. IT WAS UNKNOWN IF ANY DIAGNOSTIC TESTING OR TROUBLESHOOTING HAD OCCURRED. IT WAS REPORTED THAT THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH EVENT. THE PATIENT STATUS AT THE TIME OF REPORT WAS NOTED AS ¿ALIVE ¿ NO INJURY¿. FOLLOW UP INFORMATION RECEIVED 2 DAYS LATER REPORTED THAT THE DATE OF ONSET OF THE INFECTION WAS (B)(6) 2014. THE PRIMARY SITE OF THE INFECTION WAS NOTED AS OVER THE INS POCKET. A CULTURE WAS TAKEN INTRAOPERATIVELY LAST NIGHT (RESULTS WERE PENDING). THE TREATMENT FOR THE PATIENT INCLUDED COMPLETE REMOVAL OF THEIR INS SYSTEM (BATTERY AND LEAD). THE PATIENT WAS HOSPITALIZED ON IV ANTIBIOTICS AND WAS STILL BEING TREATED. FURTHER FOLLOW UP INFORMATION RECEIVED ON (B)(6) 2014 REPORTED THE PATIENT¿S PHYSICIAN PLANNED FOR IV ANTIBIOTIC TREATMENT FOR SEVERAL WEEKS FOR THE PATIENT AND THEN TO RE-IMPLANT WITHIN 6 WEEKS. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    369899 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R