BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2950227 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01472
    Event Type
    Injury
    Date Received
    February 8, 2013
    Report Date
    January 21, 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
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT# V063306, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE DEVICE, SERIAL #(B)(4), FOUND NO ANOMALY. ANALYSIS OF THE UNKNOWN LEAD FOUND ONE CONDUCTOR WAS BROKEN AT THE SECOND MOST DISTAL TINE, 3.7 CM FROM THE DISTAL END. CIRCUIT #1 WAS REPORTED AS OPEN.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-33 LOT# V063306, IMPLANTED: 2008 (B)(6), EXPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3889-28 LOT# UNKNOWN, PRODUCT TYPE LEAD. ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCES PRIOR TO THE PROCEDURE, AND IT WAS THOUGHT TO BE A LEAD PROBLEM. THE PATIENT WAS NOT GETTING THERAPY EITHER. IT WAS STATED THAT THE LEAD 'LOOKED FINE' DURING SURGERY, BUT THEY DECIDED TO REPLACE THE ENTIRE SYSTEM. THE PROCEDURE HAPPENED ON THE DAY OF THE REPORT AND THE PATIENT OUTCOME WAS STILL PENDING. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT PRIOR TO THE REVISION, THE PATIENT WAS FEELING STIMULATION IN HER LEFT ARM. IT WAS REPORTED THAT THERE WAS PERHAPS AN ISSUE WITH THE PATIENT'S COGNITIVE UNDERSTANDING. ADDITIONAL INFORMATION FROM THE PATIENT'S PHYSICIAN NOTED THAT THE CAUSE WAS UNKNOWN. THERE WERE ABNORMAL IMPEDANCES (>4000 OHMS) ON ELECTRODE COMBINATIONS OF C/1, 0/1, 1/2, AND 1/3. AFTER THE REVISION, IMPEDANCES RANGED FROM 547-2085 OHMS. THE PATIENT WAS SEEN FOR REPROGRAMMING ON (B)(6) 2013. THERE WAS 'QUESTIONABLE RELIABILITY' WITH STIMULATION LOCATION. THE PATIENT STATED IT WAS STIMULATING HER ABDOMEN, THIGHS AND HIPS. THE STIMULATION WAS TURNED OFF UNTIL HER BACK ISSUES WERE ADDRESSED. THE PATIENT HAD ALSO FORGOTTEN HER NEW PROGRAMMER, BUT THE PATIENT HAD REPEATEDLY FORGOTTEN HER PROGRAMMER ON PREVIOUS CLINIC VISITS. THE PHYSICIAN QUESTIONED THE PATIENT'S ABILITY TO USE THE UNIT. THE PATIENT BELIEVED IT HAD TO BE PAINFUL TO FUNCTION. THE PATIENT OUTCOME WAS REPORTED AS NO INJURY/STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54652 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00074 YR Required Intervention