BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3130740 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08209
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    January 23, 2013
    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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). FINAL ANALYSIS RESULTS PREVIOUSLY AND INCORRECTLY REPORTED IN MANUFACTURING REPORT # 3004209178-2013-06478. ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO SIGNIFICANT ANOMALIES. IT WAS NOTED THAT THERE WERE SCRATCHES, BURN MARKS, AND FOREIGN MATERIAL UNDER THE COVER. ANALYSIS OF THE TINED LEAD FOUND NO ANOMALIES. ANALYSIS OF THE PROGRAMMER FOUND NO ANOMALIES.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3889-28 LOT# V673560, IMPLANTED: 2011 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT¿S SYSTEM WAS REMOVED BECAUSE MAGNETIC RESONANCE IMAGING (MRI)WAS NEEDED. THERE WAS NO PATIENT INJURY AND SHE RECOVERED WITHOUT SEQUELA. INFORMATION PREVIOUSLY AND INCORRECTLY REPORTED IN MANUFACTURING REPORT #3004209178-2013-06478.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED INCREASED PAIN - BURNING AND ACHING, IN UPPER LEFT LEG.

    Description of Event or Problem · 1

    FURTHER INFORMATION RECEIVED REPORTED THAT, AS OF (B)(6) 2013, THE PATIENT CONTINUED TO HAVE PAIN BUT HAD IMPROVED SINCE REMOVAL OF THE IMPLANTABLE NEUROSTIMULATOR (INS). IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE PATIENT RECEIVED THE NORCO 1 TAB TID PRN PO ON (B)(6), 2013.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT INTERSTIM WAS REMOVED DUE TO ONGOING PAIN AND PATIENT CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD INGUINAL NERVE DAMAGE. THE PATIENT SYMPTOMS WERE REPORTED AS INCREASED PAIN IN UPPER LEFT LEG AND IT WAS STATED IT INVOLVED ¿INGUINAL NERVE,¿ DIFFICULTY WALKING, RATED PAIN 8 TO 10 OUT OF 10. IT WAS NOTED THAT THE PAIN CLINICIAN CANNOT ASSESS DAMAGE PER CT AND NEEDED AN MRI TO ASSESS DAMAGE. INTERVENTION INCLUDED NORCO 1 TAB TID PRN PO AND THERAPEUTIC ILOLINGUINAL NERVE BLOCK ON (B)(6) 2012 (LEFT), (B)(6) 2012 (LEFT), (B)(6) 2012 (RIGHT) AND DECEMBER 12, 2012 (LEFT) AND BILATERAL NERVE CRYONEUROLYSIS ON (B)(6) 2012. THE PATIENT OUTCOME WAS REPORTED AS ONGOING.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN MRI OF THE THORACIC SPINE ON 2013-(B)(6) AND THE IMPRESSION WAS A SMALL RIGHT PARAMEDIAN DISC PROTRUSION AT T11-T12 AND LUMBAR SPONDYLOTIC CHANGES.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED NOTED THAT REGARDING WHAT WAS THE CAUSE OF THE PATIENT'S NERVE DAMAGE/PAIN/DISC PROTRUSION, IT WAS NOTED: THE CAUSE OF THIS PATIENT'S ISSUES WAS RELATED TO HER DIAGNOSIS OF SPINA BIFIDA. REGARDING DID THE PATIENT HAVE A HISTORY OF THESE SYMPTOMS PRIOR TO IMPLANT, IT WAS NOTED: YES. REGARDING WERE THE SYMPTOMS RELATED TO THE IMPLANTED DEVICE, IT WAS NOTED: THE PATIENT REPORTED AN IMPROVEMENT FOLLOWING THE REMOVAL OF HER DEVICE, HOWEVER, SINCE HER SYMPTOMS WERE EPISODIC IN NATURE, IT IS UNCLEAR IF THE ISSUE WAS DEVICE RELATED. THE PATIENT WAS SCHEDULED FOR FOLLOW UP. REGARDING HOW WERE THE SYMPTOMS OF NERVE DAMAGE/PAIN/DIFFICULTY WALKING ADDRESSED AND WERE THE ISSUES RESOLVED, IT WAS NOTED: THE PATIENT WAS REFERRED BACK TO HER PAIN SPECIALIST AND HER DIFFICULTY WALKING NOW APPEARED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230940 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR Required Intervention