BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRIMEADVANCED

    MDR report key: 2974868 · Received February 22, 2013

    Report

    Report Number
    3004209178-2013-02998
    Event Type
    Injury
    Date Received
    February 22, 2013
    Report Date
    February 18, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID 3550-39, LOT# N329805, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 37743, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3550-39, LOT# N306799, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED NO SIGNIFICANT ANOMALY AND IT WAS NOTED IT WAS ¿FUNCTIONALLY OKAY.¿ ANALYSIS OF THE TITAN ANCHOR (LOT # N306799) REVEALED NO SIGNIFICANT ANOMALY, BUT IT WAS NOTED THE SILICONE WAS CUT. ANALYSIS OF THE TITAN ANCHOR (LOT # N329805) REVEALED NO ANOMALY. ANALYSIS OF THE LEAD REVEALED THE LEAD CONDUCTOR WAS BROKEN AT THE TITAN ANCHOR SITE. THE LEAD WAS RETURNED IN FIVE SEGMENTS; ONE DISTAL SEGMENT, ONE MEDIAL SEGMENT, AND TWO PROXIMAL SEGMENTS THAT WERE CONNECTED TO THE INS. THE PROXIMAL SEGMENTS WERE SEVERELY TWISTED AND BASED ON THE CONDITION THEY WERE NOT FUNCTIONALLY TESTED. IT WAS NOTED THE MEDIAL SEGMENT WAS ALSO NOT FUNCTIONALLY TESTED DUE TO CONDUCTOR BREAKS. THE DISTAL END WAS TESTED AND FOUND TO HAVE OPEN CIRCUITS ON ALL OF THE CONDUCTOR WIRES. IT WAS NOTED THERE WERE ALSO CONDUCTOR BREAKS ON THE DISTAL END. IT WAS ALSO NOTED THE TWISTING OF THE LEADS DID NOT APPEAR TO HAVE CAUSED THE BREAKS ON THE DISTAL END OF THE LEAD AS THE TWISTING OF THE LEAD WAS LIMITED TO THE PROXIMAL SEGMENTS ONLY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THE SYSTEM WAS EXPLANTED AS PLANNED. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. SYSTEM REPLACEMENT WAS PERFORMED DUE TO LEADS BECOMING DISLODGED, TWISTED, AND BRAIDED. IT WAS STATED THAT THE PATIENT WAS RECEIVING ADEQUATE COVERAGE AT POST-OP PROGRAMMING. BATTERY DEPLETION WAS MARKED AS NOT NORMAL. INADEQUATE COVERAGE, BREAKAGE, DISLODGEMENT, AND POSITIONING DIFFICULTY WERE ALSO NOTED AS THE REASON FOR REMOVAL. THERE WAS NO PATIENT DEATH OR INJURY. THE PATIENT RECOVERED WITHOUT SEQUELA. LESS THAN ONE MONTHS LATER IT WAS REPORTED THAT THE PAIN COVERAGE WAS VERY GOOD AND WAS "BACK TO OUTCOME OF ORIGINAL IMPLANT."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THERE WERE NO SURGICAL INTERVENTIONS PLANNED AT THE TIME OF THE REPORT. IT WAS UNKNOWN IF THERE WAS ANY DEVICE MALFUNCTION. IT WAS STATED THAT THE LEADS LOOKED LIKE THEY HAD BEEN "TWISTED INTO A GIANT BRAID, KNOTTED IN THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET." IT WAS NOTED THAT THE PATIENT WAS NOT RECEIVING EFFECTIVE THERAPY. LESS THAN TWO WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS GOING TO HAVE HER ENTIRE SYSTEM REPLACED ON (B)(6) 2013. THERE WAS NO CONFIRMATION FROM HEALTHCARE PROFESSIONAL'S OFFICE YET.

    Description of Event or Problem · 1

    ADDITIONAL REVIEW DETERMINED THE REPORTER HAD STATED THE PATIENT¿S ISSUE LOOKED LIKE ¿TWIDDLER¿S SYNDROME¿ WITH THE IMPLANTABLE NEUROSTIMULATOR AND LEADS.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT WENT TO THEIR PHYSICIAN TO FOLLOW UP ON A CT-MYELOGRAM BECAUSE OF A "SERIOUS INCREASE IN LOW BACK PAIN." IT WAS STATED THAT THE PATIENT HAD "ADVANCED OR EXTREME" ARACHNOIDITIS. IT WAS NOTED THAT THE PATIENT'S STIMULATOR HAD LOST THERAPEUTIC BENEFIT IN THE "LOW-BACK." THE PATIENT REPORTEDLY HAD "GOOD BACK PAIN RELIEF," BUT OVER THE PRIOR 2 MONTHS, THE PAIN WAS "OUT OF CONTROL." IT WAS STATED THAT THERE WERE PROGRAMMING ATTEMPTS AND IMPEDANCES WERE ALL WITHIN NORMAL RANGE. NO INTERVENTION WAS PLANNED AT THE TIME OF THE REPORT. THE PATIENT REPORTEDLY WOULD BE RECEIVING NEW ORAL MEDICATIONS AND INTERVENTIONAL INJECTIONS. IT WAS LATER REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS "NOT WORKING" AND THAT "IT WAS BURNING." IT WAS STATED THAT ONE COULD "SEE THE WIRE" OUTLINE IN HER ABDOMEN. IT WAS FURTHER STATED THAT "SOMETHING IN HER INS POCKET LOOKED LIKE IT WOULD COME THROUGH THE SKIN SOON." IT WAS NOTED THAT IT WAS "PALPABLE TO THE TOUCH." IT WAS STATED THAT 16 OF THE 18 CONTACTS READ >10000 OHMS. IT WAS REPORTED THAT THE PATIENT FELL ON HER RIGHT SIDE AND STATED SHE HIT HER KNEE, INS POCKET AND SHOULDER ON THE FLOOR. IT WAS THEN REPORTED THAT HER PATIENT PROGRAMMER WOULD NOT TURN ON THE STIMULATION. IT WAS REPORTED THAT THE PATIENT AGREED TO A REVISION IF SHE PASSED A CARDIAC CLEARANCE. NO INTERVENTIONS WERE SCHEDULED AS OF THIS REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78531 PRIMEADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37702

    Patients

    Seq Age Sex Outcome Treatment
    1 00054 YR Required Intervention