BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1002286 · Received February 22, 2008

    Report

    Report Number
    3004209178-2008-00895
    Event Type
    Injury
    Date Received
    February 22, 2008
    Date of Event
    January 22, 2008
    Report Date
    January 23, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT DISPLAYED SIGNS OF INFECTION WITH REDNESS ON THE RIGHT SIDE. THE PT STATED THE INFECTION MAY HAVE OCCURRED FOLLOWING A BATTERY REPLACEMENT IN 2007. THE PT MET WITH THE HCP IN 2008 AND DISCUSSED PERFORMING DIAGNOSTIC TESTING FOR ADD'L INFO ON THE INFECTION. THE PATIENT REPORTED BEGINNING ANTIBIOTIC TREATMENT SOMETIME AFTER THREE DAYS LATER. NO OTHER TESTING, SYMPTOMS OR OUTCOME WAS REPORTED. ADD'L INFO HAS BEEN REQUESTED FROM HCP, BUT WAS NOT AVAILABLE ON THE DATE OF THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HCP INDICATED THE INFECTION WAS AT THE DEVICE POCKET INCISION. ADDITIONAL SYMPTOMS INCLUDED SWELLING AT THE INFECTION SITE. NO CULTURES WERE OBTAINED. THE PATIENT WAS TREATED WITH IV ANTIBIOTICS. THE HCP INDICATED THE PATIENT HAD A UTI THAT RESOLVED AFTER 10 DAYS OF ANTIBIOTICS. THE INFECTION AT THE DEVICE POCKET INCISION CONTINUES TO BE ONGOING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT HAD SPENT 51 DAYS IN THE NURSING HOME AND HOSPITAL AFTER THE INFECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE PATIENT SPENT 4 DAYS IN THE HOSPITAL AND 60 DAYS IN THE NURSING HOME DUE TO THE INFECTION. THE PATIENT'S SPOUSE STATED, "THE INFECTION WAS CLEARED LONG AGO".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention IMPLANTED| EXTENSION MODEL 7482 LOT# NGK017150N| LEAD MODEL 3387 LOT# J0211551V| LEAD MODEL 3387 LOT# J0214131V| IMPLANTED| EXPLANTED| IMPLANTED| EXPLANTED| EXPLANTED