BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2831329 · Received November 14, 2012

    Report

    Report Number
    3004209178-2012-10227
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT # V972782, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS SHOWED THAT IT WAS FUNCTIONALLY OKAY AND NO SIGNIFICANT ANOMALIES WERE FOUND. ANALYSIS OF THE LEAD SHOWED THAT NO ANOMALIES WERE FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS "TOLD BY HER PHYSICIAN THAT SHE HAD A SEROMA AND THERE WAS REDNESS AND SWELLING AT THE IMPLANT SITE." IT WAS NOTED THAT THE "SWELLING WAS GOING DOWN AND IT WAS FEELING BETTER." IT WAS NOTED THAT THE PATIENT HAD AN INFECTION. IT WAS FURTHER NOTED THAT "THE SITE WAS WARM TO THE TOUCH AND SWOLLEN." IT WAS NOTED THAT THIS WAS AT THE POCKET SITE. IT WAS NOTED THAT THE PATIENT WAS GIVEN ANTIBIOTICS. IT WAS NOTED THAT THE PATIENT "RAN A FEVER OF 100 DEGREES FOR A FEW DAYS." IT WAS NOTED THAT THE PATIENT'S DEVICE "WAS DEFINITELY HELPING HER URINARY CONTROL." IT WAS NOTED THAT THE PATIENT HAD A SCHEDULED APPOINTMENT WITH HER PHYSICIAN ON (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING HER DEVICE OR THERAPY, BUT SHE WAS WORKING WITH HER PHYSICIAN AND MANUFACTURING REPRESENTATIVE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS GIVEN PERIOPERATIVE ANTIBIOTICS AND ORAL ANTIBIOTICS. IT WAS NOTED THAT THE PATIENT DID NOT HAVE MENINGITIS. IT WAS NOTED THAT THE PATIENT EXPERIENCED REDNESS AT THE INFECTION SITE. IT WAS NOTED THAT THE PRIMARY LOCATION OF THE INFECTION WAS AT THE DEVICE POCKET. A CULTURE WAS NOT OBTAINED. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF DIABETES BEFORE THE DEVICE WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT'S INFECTION WAS RESOLVED.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE WAS EXTREMELY SENSITIVE TO TOUCH AND MORE PAINFUL THAN BEFORE. IT WAS ALSO NOTED, IT WAS SLIGHTLY DISCOLORED AND WARM TO THE TOUCH. IT WAS NOTED, THE PATIENT INCREASED THEIR STIMULATION TO ABOUT 4 VOLTS ABOUT 2-3 WEEKS PRIOR AND THEY DID NOT KNOW IF THAT HAD MADE A DIFFERENCE IN THE INS SITE. THE PATIENT HAD NOT DECREASED STIMULATION OR CHANGE PROGRAMS BECAUSE, THE HIGHER SETTING HAD HELPED WITH SYMPTOM CONTROL. IT WAS NOTED, THE PATIENT IS A DIABETIC AND CARRIES THEIR EXCESS WEIGHT IN THEIR HIP/BUTTOCK AREA. IT WAS ALSO NOTED, THE HEALTH CARE PROFESSIONAL (HCP) DID MENTION MOVING THE INS AT ONE POINT. IT WAS NOTED, THE PATIENT HAD SEEN THEIR HCP FOR THIS ISSUE THREE TIMES AND THEIR NEXT APPOINTMENT WAS SCHEDULED FOR (B)(6) 2013. IT WAS LATER REPORTED THE INS WAS REMOVED DUE TO INFECTION. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention