BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM NEUROSTIMULATOR, UNKNOWN

    MDR report key: 4950796 · Received July 29, 2015

    Report

    Report Number
    3007566237-2015-02139
    Event Type
    Injury
    Date Received
    July 29, 2015
    Date of Event
    February 24, 2014
    Report Date
    July 6, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    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. EVENT DATE: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE: EXTENSION; PRODUCT ID NEU_INTERSTIM_INS, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EVENTS OCCURRED IN THE 2009-2010 RANGE. FOR EVENT 1, NO SOURCE WAS DETERMINED FOR THE EXPLANT DUE TO INFECTION. FOR EVENT 2, THE AUTHOR NOTED THAT THE EXPLANT COULD NOT BE LINKED TO THE PATIENT'S COMPLAINTS.

    Description of Event or Problem · 1

    PARNELL, B. A., HOWARD, J. F., JR., GELLER, E. J. THE EFFECT OF SACRAL NEUROMODULATION ON PUDENDAL NERVE FUNCTION AND FEMALE SEXUAL FUNCTION. NEUROUROLOGY AND URODYNAMICS. 2015; 34(5):456-460. DOI 10.1002/NAU.22579. SUMMARY: TO QUANTIFY CHANGES IN PUDENDAL NERVE FUNCTION WITH SACRAL NEUROMODULATION (SNM). TO UNDERSTAND THE RELATIONSHIP OF PUDENDAL NERVE FUNCTION TO SNM TREATMENT RESPONSE FOR OVERACTIVE BLADDER. TO ASSESS THE RELATIONSHIP BETWEEN FEMALE SEXUAL FUNCTION AND PUDENDAL NERVE FUNCTION AFTER SNM. METHODS: WOMEN UNDERGOING SNM BETWEEN JANUARY 2010 AND MAY 2011 WERE ENROLLED. BASELINE PUDENDAL NERVE TERMINAL MOTOR LATENCIES (PNTML) WERE MEASURED BILATERALLY. SUBJECTS UNDERWENT PERIPHERAL NERVE EVALUATION (PNE) PRIOR TO SNM THERAPY.PNTML WAS MEASURED AT 1 AND 6 WEEKS AFTER SACRAL NEUROMODULATOR IMPLANT. WOMEN WHO DID NOT UNDERGO PERMANENT IMPLANTATION WERE REASSESSED AT THE END OF THE 1-WEEK PNE TESTING PHASE. PELVIC FLOOR AND SEXUAL FUNCTION QUESTIONNAIRES WERE ADMINISTERED AT BASELINE AND FOLLOW-UP TO ASSESS PELVIC FLOOR AND SEXUAL FUNCTION. RESULTS: OF 34 WOMEN ENROLLED, 31 WERE EVALUATED. MEAN AGE WAS 67.4_14.2 YEARS WITH 29/34 (85.3%) TREATED FOR REFRACTORY OVERACTIVE BLADDER. THIRTY OF 31 (96.7%) WENT ON TO A PERMANENT IMPLANT. PNE SUCCESS RATE WAS 73.5% (25/33). MEAN PNTML CHANGED FROM 2.74_0.52 MSEC AT BASELINE TO 2.57_0.50 MSEC AT 6 WEEKS POSTOP (P¼0.198). BASELINE AMPLITUDE REMAINED STABLE AT 1 AND 6 WEEKS. AT 6 WEEKS PISQ-12 SCORES SHOWED IMPROVED SEXUAL FUNCTION (P¼0.034) AND PFDI-20 AND PFIQ-7 SCORES SHOWED IMPROVED PELVIC FLOOR, COLORECTAL AND URINARY SYMPTOMS (P <(><<)>0.05). CONCLUSIONS: WOMEN WITH REFRACTORY OVERACTIVE BLADDER AND NONOBSTRUCTIVE URINARY RETENTION HAVE ABNORMAL PUDENDAL NERVE FUNCTION, WHICH SHOWED A NON-SIGNIFICANT TREND TOWARD IMPROVEMENT AFTER SNM. SEXUALLY ACTIVE WOMEN UNDERGOING SACRAL NEUROMODULATION EXPERIENCED IMPROVEMENT IN SEXUAL FUNCTION. QUALITY OF LIFE IMPROVED DUE TO IMPROVEMENT IN URINARY AND COLORECTAL FUNCTION. REPORTED EVENT(S) 1. ONE PATIENT WITH SACRAL NEUROMODULATION (SNM) DEVELOPED AN IMPLANT INFECTION ULTIMATELY REQUIRING A FULL EXPLANT. THE PATIENT UNDERWENT SUCCESSFUL RE-IMPLANTATION AFTER RESOLUTION OF THE PROBLEM. 2. ONE PATIENT WITH SACRAL NEUROMODULATION (SNM) REQUESTED AN EXPLANT DESPITE RESOLUTION OF HER SYMPTOMS DUE TO NEW ONSET BILATERAL LOWER EXTREMITY EDEMA. THE PATIENT UNDERWENT SUCCESSFUL RE-IMPLANTATION AFTER RESOLUTION OF THE PROBLEM. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. 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
    493517 INTERSTIM NEUROSTIMULATOR, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention