BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GENESYS HTA PROCERVA®

    MDR report key: 2891259 · Received December 31, 2012

    Report

    Report Number
    3005099803-2012-06353
    Event Type
    Injury
    Date Received
    December 31, 2012
    Date of Event
    December 1, 2012
    Report Date
    December 7, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER IS NOT KNOWN PER COMPLAINANT; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE CAN NOT BE DETERMINED. DEVICE AVAILABLE FOR EVALUATION: DEVICE DISPOSED OF. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT WAS DISPOSED; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. AT THIS TIME, WE ARE UNABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. IF THERE IS ANY FURTHER RELEVANT INFORMATION A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A GENESYS HTA (HYDROTHERMABLATION) PROCERVA PROCEDURE SET WAS USED DURING AN HTA PROCEDURE ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, THE HTA PROCEDURE ITSELF WAS PERFORMED SUCCESSFULLY WITH NO PROBLEMS ENCOUNTERED DURING THE ACTUAL TREATMENT. THE PHYSICIAN STATED THE PATIENT RECEIVED A COMPLETE ABLATION. HOWEVER, SEVERAL HOURS LATER, THE PATIENT PHONED THE PHYSICIAN COMPLAINING OF MILD PAIN AND A SLIGHT FEVER. THE PATIENT WAS DIRECTED TO TAKE A COMBINATION OF MOTRIN AND TYLENOL FOR SYMPTOMATIC RELIEF. AFTER THE DOCTOR WAS CONTACTED AGAIN THE NEXT DAY FROM THE PATIENT EXPERIENCING ELEVATED SYMPTOMS, SHE PRESCRIBED ANTIBIOTICS. HOWEVER, THE PATIENT EXPERIENCED A BAD REACTION AND WAS DIRECTED TO GO TO THE EMERGENCY ROOM. SEVERAL RADIOLOGICAL AND LABORATORY TESTS WERE PERFORMED ULTIMATELY SHOWING EVIDENCE OF A GROUP A STREPTOCOCCAL INFECTION AND SUBSEQUENT TOXIC SHOCK SYNDROME. THE PATIENT WAS ADMITTED TO THE HOSPITAL. A COMBINATION OF CLINDAMYCIN AND ROCEFIN ANTIBIOTICS WERE ADMINISTERED TO THE PATIENT. THIS TREATMENT PROVED SUCCESSFUL AND THE PATIENT WAS RELEASED ON (B)(6) 2012 WITH A PRESCRIPTION FOR KEFLEX. THE PHYSICIAN STATED SHE DID NOT EXPECT THE PATIENT TO HAVE ANY RESIDUAL EFFECTS FROM THE INFECTION. AT THIS TIME THE PATIENT IS STILL BEING MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GENESYS HTA PROCERVA® DEVICE, THERMAL ABLATION, ENDOMETRIAL MNB BOSTON SCIENTIFIC - MARLBOROUGH M006580211

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| R