BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM NEUROSTIMULATOR, UNKNOWN

    MDR report key: 4210617 · Received October 29, 2014

    Report

    Report Number
    3007566237-2014-03156
    Event Type
    Injury
    Date Received
    October 29, 2014
    Report Date
    October 6, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    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. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. CONCOMITANT: PRODUCT ID 3889, LOT# UNKNOWN, PRODUCT TYPE LEAD. PRODUCT ID NEU_INTERSTIM_INS, LOT# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    LEVIN, P.J., SIDDIQUI, N.Y., WU, J.M., AMUNDSEN, C.L. PSYCHOSOCIAL FACTORS RELATED TO THE USE OF INTERSTIM(R) FOR THE TREATMENT OF REFRACTORY OVERACTIVE BLADDER. FEMALE PELVIC MEDICINE <(>&<)> RECONSTRUCTIVE SURGERY. 2014;20(5):272-275. DOI: 10.1097/SPV.0000000 000000062 SUMMARY: SACRAL NEUROMODULATION IS A WELL-ESTABLISHED TREATMENT OF REFRACTORY OVERACTIVE BLADDER (OAB). ALTHOUGH LITERATURE EXISTS ON THE PSYCHOSOCIAL IMPACT OF OTHER IMPLANTED MEDICAL DEVICES, DATA DO NOT EXIST FOR INTERSTIM\ THERAPY. WE AIM TO EVALUATE THE RELATIONSHIP BETWEEN OPTIMISM AND TREATMENT SATISFACTION IN WOMEN UNDERGOING INTERSTIM FOR REFRACTORY OAB AND CHANGE IN OAB SYMPTOMS. ADULT WOMEN UNDERGOING INTERSTIM THERAPY FOR REFRACTORY OAB COMPLETED A SERIES OF VALIDATED QUESTIONNAIRES BEFORE TEST STIMULATION ASSESSING OPTIMISM, URINARY SYMPTOM SEVERITY, DEPRESSION, AND BODY IMAGE. QUESTIONNAIRES INCLUDED THE LIFE ORIENTATION TEST-REVISED, OAB QUESTIONNAIRE-SHORT FORM, MAJOR DEPRESSION INVENTORY, AND A BODY IMAGE SCALE. THREE MONTHS POSTOPERATIVELY, PARTICIPANTS REPEATED THE QUESTIONNAIRES TO ASSESS URINARY SYMPTOMS, DEPRESSION, AND BODY IMAGE AND COMPLETED THE OAB SATISFACTION WITH TREATMENT QUESTIONNAIRE (OAB-SAT-Q). CORRELATIONS ASSESSED THE RELATIONSHIP BETWEEN THE LIFE ORIENTATION TEST- REVISED SCORE AND OAB-SAT-Q SUBSCALE SCORES, AND THE OAB QUESTIONNAIRE SUBSCALE CHANGE SCORES. SUBJECTS ALSO COMPLETED THE NONVALIDATED QUESTIONS AIMED AT PATIENTS CONCERNS REGARDING THE IMPLANTED DEVICES PREOPERATIVELY AND POSTOPERATIVELY. TWENTY-EIGHT WOMEN WERE INCLUDED. LEVEL OF OPTIMISM WAS WEAKLY CORRELATED WITH SUBJECT SATISFACTION ACROSS ALL OAB-SAT-Q SUBSCALES (R VALUE OF J0.11, J0.21, J0.42, AND J0.20 FOR SATISFACTION, ENDORSEMENT, ADVERSE EFFECTS, AND CONVENIENCE, RESPECTIVELY). OPTIMISM HAD A WEAK CORRELATION WITH CHANGE IN OAB SYMPTOMS IN SYMPTOM SEVERITY AND HEALTH-RELATED QUALITY OF LIFE SUBSCALES. COMPARISON OF PREOPERATIVE AND POSTOPERATIVE QUESTIONNAIRES DEMONSTRATED STATISTICALLY SIGNIFICANT IMPROVEMENTS IN DEPRESSION, BODY IMAGE, SYMPTOM SEVERITY, AND HEALTHRELATED QUALITY OF LIFE. PATIENTS CONCERNS REGARDING IMPLANTED DEVICES CHANGED ONLY MARGINALLY. THE LEVEL OF OPTIMISM DID NOT CORRELATE WITH SATISFACTION WITH INTERSTIM TREATMENT, CHANGE IN OAB SYMPTOMS, OR OAB-RELATED QUALITY OF LIFE. HEALTH-RELATED QUALITY OF LIFE, OAB SYMPTOMS, DEPRESSION, AND BODY IMAGE IMPROVED AFTER INTERSTIM TREATMENT. REPORTED EVENTS: ONE PATIENT EXPERIENCED LEAD MIGRATION DURING THE TEST PHASE AND UNDERWENT REVISION OF LEAD AND GENERATOR PLACEMENT SIMULTANEOUSLY. ONE PATIENT UNDERWENT A REVISION SURGERY. THE REASON FOR REVISION WAS NOT STATED. ONE PATIENT EXPERIENCED DIARRHEA POSTOPERATIVELY THAT RESPONDED TO ORAL ANTIBIOTICS. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: INTERSTIM DEVICE AND TINED LEAD MODEL 3889 FURTHER INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    691618 INTERSTIM NEUROSTIMULATOR, UNKNOWN STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Required Intervention