BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM NEUROSTIMULATOR, UNKNOWN

    MDR report key: 3884441 · Received June 19, 2014

    Report

    Report Number
    3007566237-2014-01726
    Event Type
    Injury
    Date Received
    June 19, 2014
    Report Date
    June 3, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INTERSTIM_INS, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL PATIENTS RECOVERED FROM THE INFECTIONS AND ALL BUT TWO HAD REPEAT IMPLANTS. THE REPORTER STATED THAT THE EVENTS WERE INFECTIOUS COMPLICATIONS AND NOT RELATED TO ANY DEVICE FAILURE.

    Description of Event or Problem · 1

    HARAWAY, A.M., CLEMENS, J.Q., HE, C., STROUP, C., ATIEMO, H.O., CAMERON, A.P. DIFFERENCES IN SACRAL NEUROMODULATION DEVICE INFECTION RATES BASED ON PREOPERATIVE ANTIBIOTIC SELECTION. INTERNATIONAL UROGYNECOLOGY JOURNAL. 2013;24(12):2081-2085. DOI 10.1007/S00192-013-2121-Z. SUMMARY: AFTER SNM IMPLANTATION THE MOST SIGNIFICANT COMPLICATION THAT CAN OCCUR IS WOUND INFECTION, WHICH TYPICALLY REQUIRES REMOVAL OF ALL COMPONENTS. SUCH INFECTIONS HAVE BEEN REPORTED IN 5¿11 % OF PATIENTS, BUT LITTLE IS KNOWN ABOUT RISK FACTORS. THE OBJECTIVE OF THIS ANALYSIS IS TO DETERMINE OUR POSTOPERATIVE WOUND INFECTION RATE AFTER SNM IMPLANTATION, AND EXAMINED VARIOUS POTENTIAL PREDICTIVE FACTORS. OUR HYPOTHESIS IS THAT PERIOPERATIVE ANTIBIOTIC SELECTION IS RELATED TO THE RISK OF INFECTIONS. A RETROSPECTIVE REVIEW WAS PERFORMED OF ALL PATIENTS WHO UNDERWENT SNM IMPLANTATION BY ONE OF THREE SURGEONS FROM 2007 TO 2010. PREOPERATIVE ANTIBIOTICS WERE ADMINISTERED ACCORDING TO SURGEON PREFERENCE, AND INCLUDED CEFAZOLIN ALONE, VANCOMYCIN ALONE, OR VANCOMYCIN WITH GENTAMICIN. PREDICTORS OF WOUND INFECTION WERE EVALUATED USING MULTIVARIATE TECHNIQUES. VARIABLES EXAMINED INCLUDED PREOPERATIVE ANTIBIOTIC REGIMEN, SURGEON, LOCATION (OUTPATIENT SURGERY CENTER VS UNIVERSITY HOSPITAL), GENDER, COMORBIDITIES (DIABETES MELLITUS, IMMUNOSUPPRESSION AND SMOKING), HISTORY OF URINARY TRACT INFECTIONS, AND PREOPERATIVE SKIN PREPARATION. A TOTAL OF 136 PATIENTS UNDERWENT SNM IMPLANTATION, AND 8 (5.9 %) EXPERIENCED INFECTIONS THAT REQUIRED DEVICE EXPLANTATION. CEFAZOLIN ALONE WAS LESS EFFECTIVE IN PREVENTING INFECTION COMPARED WITH THE OTHER ANTIBIOTIC REGIMENS (P=0.03). THE ODDS OF HAVING AN INFECTION IN CEFAZOLIN-TREATED PATIENTS WAS 7.3 TIMES THAT OF OTHER PATIENTS TREATED WITH ANOTHER ANTIBIOTIC REGIMEN. SEVEN OUT OF THE EIGHT INFECTIONS WITH EXPLANT GREW STAPHYLOCOCCUS AUREUS RESISTANT TO CEPHALOSPORINS. NONE OF THE OTHER VARIABLES PROVED TO BE A STATISTICALLY SIGNIFICANT CONTRIBUTOR. PREOPERATIVE ANTIBIOTIC SELECTION WAS A SIGNIFICANT FACTOR IN PREVENTING SUBSEQUENT INFECTION AND EXPLANTATION FOLLOWING SNM PLACEMENT. REPORTED EVENTS: ONE PATIENT EXPERIENCED AN INFECTION REQUIRING EXPLANT 150 DAYS AFTER IMPLANT FOLLOWING A MINOR TRAUMA. THE REPORTER STATED THAT THE PATIENT HAD BEEN EXPERIENCING PAIN SINCE IMPLANTATION WITH NO CLINICAL SIGNS OF INFECTION UNTIL THE TRAUMA. IT WAS REPORTEDLY UNCLEAR IF THE INFECTION OCCURRED BECAUSE OF THE TRAUMA OR WAS A SLOWLY PROGRESSIVE INFECTION. THE REPORTER STATED THAT THE PATIENT WAS NOT TREATED CONSERVATIVELY GIVEN THE PRESENCE OF PURULENCE. IT WAS NOTED THAT PSEUDOMONAS WAS CULTURED IN THE EXPLANTED DEVICE. SEVEN PATIENTS EXPERIENCED AN INFECTION REQUIRING EXPLANT A MEAN OF 28.3 DAYS AFTER IMPLANT. THE REPORTER STATED THAT THE PATIENTS WERE NOT TREATED CONSERVATIVELY GIVEN THE PRESENCE OF PURULENCE IN ALL CASES. IT WAS NOTED THAT STAPHYLOCOCCUS AUREUS THAT WAS RESISTANT TO CEPHALOSPORINS WAS CULTURED FROM THE DEVICES. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: INTERSTIM IMPLANTABLE NEUROSTIMULATOR (MODEL # UNKNOWN) FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362049 INTERSTIM NEUROSTIMULATOR, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00049 YR Required Intervention