BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3536058 · Received December 24, 2013

    Report

    Report Number
    3007566237-2013-04144
    Event Type
    Injury
    Date Received
    December 24, 2013
    Date of Event
    February 2, 2013
    Report Date
    December 3, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. (B)(4).

    Description of Event or Problem · 1

    KHUNDA, A., KARMARKAR, R., ABTAHI, B., GONZALES, G., ELNEIL, S. PREGNANCY IN WOMEN WITH FOWLER'S SYNDROME TREATED WITH SACRAL NEUROMODULATION. INTERNATIONAL UROGYNECOLOGY JOURNAL. 2013;24(7):1201-1204. DOI 10.1007/S00192-012-1999-1. SUMMARY: OUR AIM WAS TO DETERMINE THE IMPACT OF PREGNANCY ON SACRAL NEUROMODULATION (SNM) AND VICE VERSA IN PATIENTS WITH FOWLER¿S SYNDROME (FS), WHICH IS TYPIFIED BY CHRONIC URINARY RETENTION (CUR). WE PERFORMED A RETROSPECTIVE STUDY OF PREGNANCY IN PATIENTS WITH FS WHO UNDERWENT A TWO-STAGE SNM IMPLANTATION. DATA WERE OBTAINED USING A STANDARD QUESTIONNAIRE AND CLINICAL INTERVIEW. THERE WERE A TOTAL OF TEN PATIENTS WITH 13 PREGNANCIES. THE SNM WAS SWITCHED OFF IN TEN OF THE 13 PREGNANCIES, WITH CUR RECURRING IN NINE OF THE TEN PREGNANCIES AND RECURRENT URINARY TRACT INFECTIONS (UTI) OCCURRING IN FOUR OF THESE PREGNANCIES (MORE THAN THREE UTI IN THE PREGNANCY). THOSE IN WHOM THE DEVICE WAS LEFT ON CONTINUED TO VOID NORMALLY. ONE WOMAN HAD A FIRST TRIMESTER MISCARRIAGE, EIGHT PREGNANCIES WENT TO TERM, AND FOUR DELIVERIES WERE PREMATURE. CAESAREAN SECTION WAS PERFORMED IN EIGHT PREGNANCIES FOR OBSTETRIC REASONS. FOUR PREGNANCIES RESULTED IN A VAGINAL DELIVERY. THERE WERE NO CONGENITAL ANOMALIES REPORTED. FOLLOWING DELIVERY, FOUR OF NINE WOMEN EXPERIENCED DYSFUNCTION OF THEIR SNM DEVICE WHEN IT WAS SWITCHED BACK ON. TURING OFF THE SNM DURING PREGNANCY RESULTS IN RECURRENCE OF CUR, WITH AN INCREASED RISK OF RECURRENT UTI ASSOCIATED WITH PRETERM DELIVERY. THIS DID NOT IMPACT FOETAL WELL-BEING. THE OPTION OF KEEPING THE SNM ON DURING PREGNANCY SHOULD THEREFORE BE CONSIDERED, AND AS CAESAREAN SECTION AFFECTS THE SNM DEVICE, WE ADVISE THAT CAESAREAN SECTION SHOULD ONLY BE PERFORMED FOR OBSTETRIC REASONS. REPORTED EVENT: ONE FEMALE PATIENT WITH SACRAL NEUROMODULATION (SNM) FOR CHRONIC URINARY RETENTION HAD TO HAVE THE IMPLANTABLE NEUROSTIMULATOR (INS) EXPLANTED DUE TO LACK OF EFFICACY. THE REPORTER STATED THAT THE PATIENT HAD TURNED THE INS OFF DURING PREGNANCY AND EXPERIENCED SNM DYSFUNCTION AFTER TURNING THE INS BACK ON AFTER DELIVERY. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WHO HAD HAD THE DEVICE EXPLANTED DUE TO LACK OF EFFICACY HAD A NEW DEVICE IMPLANTED SEVERAL MONTHS LATER. IT WAS NOTED THAT PRIOR TO EXPLANT REPROGRAMMING HAD BEEN ATTEMPTED AND THERE HAD BEEN A SURGICAL REVIEW OF THE ELECTRODE¿S POSITION. THE REPORTER STATED THAT THE NEWLY IMPLANTED DEVICE WORKED AND VOIDING WAS RESTORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674105 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention