BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5678619 · Received May 25, 2016

    Report

    Report Number
    3004209178-2016-10251
    Event Type
    Injury
    Date Received
    May 25, 2016
    Report Date
    August 27, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V192542, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND THE OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28, LOT# V192542, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    DUE TO IMRDF HARMONIZATION, PREVIOUSLY SUBMITTED DEVICE, METHOD, RESULT, AND CONCLUSION CODES RELATED TO THIS EVENT WERE UPDATED. ADDITIONAL COMPLAINT REGARDING NEW DEVICE FILED IN REGULATORY REPORT 3004209178-2018-19170. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT THE PATIENT HAD A SHARP PAIN IN THE BACK. NO TROUBLESHOOTING OR INTERVENTIONS HAD BEEN PERFORMED. THE PATIENT HAD DISMISSED HIS HEALTHCARE PROFESSIONAL (HCP). THE PATIENT NEEDED A NEW HCP FOR SOME REPAIRS AND TO REPLACE THE BATTERY FOR THE IMPLANTABLE NEUROSTIMULATOR (INS). THE INS HAD BEEN IN 7 YEARS AND IT WAS TIME TO CHANGE THE BATTERY. THERE WAS NO ALLEGATION ABOUT LONGEVITY. EVERY TIME THE PATIENT SAT ON THE TOILET, HE FELT A SHARP PAIN IN HIS BACK. HE THOUGHT THE LEAD AND INS CONNECTION WAS DAMAGED. IT WAS NOTED THAT HE HAD LOST 80 POUNDS IN THE LAST COUPLE YEARS. THE SHARP PAIN STARTED MORE RECENTLY AND HE FIRST NOTICED IT IN 2016 WITHIN THE LAST FEW MONTHS. THE PATIENT ADDED THAT HE HAD ALWAYS HAD CHRONIC PAIN AND USED LIDODERM PATCHES. IT WAS CONFIRMED THAT THIS WAS PRE-EXISTING AND UNRELATED. THE PATIENT WAS NO LONGER ABLE TO GET THOSE PATCHES, SO HE NO LONGER USED THEM. THE PATIENT BELIEVED THE LIDODERM PATCHES WERE COVERING THE SHARP PAIN, SO HE JUST NOTICED THE PAIN WHEN HE STOPPED THE PATCHES. IT WAS UNKNOWN WHEN THIS OCCURRED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THIS IMPLANT WAS NOT WORKING VERY WELL FOR HIS SYMPTOMS, SO HE HAD IT REMOVED AND A NEW ONE PUT IN. PATIENT STATED THAT HIS HEALTHCARE PROVIDER (HCP) DIDN'T WANT TO BELIEVE THAT THE DEVICE WASN'T WORKING AND PATIENT TRIED TO GET IT REPLACED FOR 6 MONTHS. FINALLY, PATIENT WENT TO NEW HCP WHO REPLACED DEVICE. THE PATIENT HAD A REVISION ON (B)(6) 2016 AND NEW DEVICE WAS IMPLANTED. IT WAS NOTED THAT THE PATIENT RECOVERED COMPLETELY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT IN THE EVENT DESCRIPTION. THE PATIENT INDICATORS FOR USE ARE FOR GASTROINTESTINAL/ PELVIC FLOOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER (CON). IT WAS REPORTED THAT THE PATIENT HAD A HEAD SCAN, BUT WAS WONDERING ABOUT THE CERVICAL SCAN AGAIN. IT WAS CONFIRMED THAT IT WAS UNRELATED TO THE IMPLANT, RATHER IT WAS FOR A C6/C7 FUSION THAT EITHER FAILED OR WAS BROKEN. THEY COULDN'T SEE IT ON A CT SCAN, SO THEY WERE CONSIDERING A MRI OR EXPLORATORY SURGERY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER: PATIENT PREVIOUSLY REPORTED HIS DEVICE HAD NOT BEEN EFFECTIVE AND SAID HE IS NOT SURE THE DEVICE IS WORKING THAT WELL EVEN SINCE REPLACEMENT. PATIENT SAID THE DEVICE NEVER REALLY WORKED, HE HAS SEVERE INCONTINENCE, LEAKAGE AND FREQUENCY. PATIENT HAS TO WEAR A DIAPER. ADDITIONAL MEDICAL INFORMATION WAS REPORTED: PATIENT HAS A PENILE IMPLANT AND HAS HAD A LOT OF ISSUES WITH IT. PATIENT SAID HE WAS DISCHARGED FROM THE CLINIC HE WAS GOING TO IN 2016. PATIENT SAID HE DIDN'T THINK THE DEVICE WAS WORKING SO THEY REPLACED THE DEVICE THEN FOUND NO ISSUE WITH THE DEVICE. PATIENT SAID THEY OFFERED TO REMOVE THE DEVICE, BUT HE DECLINED TO HAVE IT REMOVED THEN THEY DISCHARGED HIM. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335327 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention