BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2979372 · Received February 26, 2013

    Report

    Report Number
    3004209178-2013-03094
    Event Type
    Malfunction
    Date Received
    February 26, 2013
    Report Date
    February 11, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# VA02NM4, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# VA02NM4, IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THAT THE PATIENT HAD "DECREASED DYSKINESIA." PLEASE SEE MFR. REPORT # 3004209178-2013-03095 FOR INFORMATION ON THE PATIENT'S OTHER DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD 4 LEADS, 2 IN STN TARGET AREA, 2 IN GPI TARGET AREA AND TWO PRIMARY CELL ACTIVA DEVICES. (B)(6) 2012 THEY IMPLANTED GPI PRIMARY CELL. THE PATIENT HAD GONE 7 WEEKS WITHOUT THIS BATTERY. THEY RETESTED, CLEANED AND THEN ALL IMPEDANCES WERE IN NORMAL RANGE. THEY THEN DID THE OTHER SIDE (OTHER PRIMARY CELL DEVICE) THAT WAS LINKED TO STN TARGET AREA, TO EXTRACT THE RECHARGABLE, THEY DISSECTED FROM RECHARGABLE, CLEANED IT ALL. 1 WIRE "LOOKED LIKE HELD TOGETHER BY SCAR TISSUE." WHEN CLEANED OUT, IT "LOOKED FLIMSY." THEY CONNECTED TO PC, THE WIRE (EXTENSION) LOOKED LIKE IT WOULD BE AN ISSUE, ALL IMPEDANCES WERE HIGH. THE EXTENSION LOOKED DAMAGED AND THE HEALTHCARE PROFESSIONAL WANTED IT REPLACED. THEY REPLACED EXTENSION. INTRAOPERATIVE IMPEDANCES WERE STILL HIGH. THE CONCLUSION WAS THAT LEAD WAS THE ISSUE. LEFT AND RIGHT STN, THE SAME CONTACTS WERE STILL HIGH. C0,01,02,03 AND C08, 0809, 0811. ISSUE WAS NOT RESOLVED FROM PRE-OP EVEN WITH BRAND NEW BATTERY AND EXTENSION. THEY TOOK MUCH EFFORT TO CLEAN, RETEST ETC. THE PATIENT HAD SEVERE PARKINSON'S. DYSKINESIA WAS MUCH IMPROVED WITH NEW LEADS IN GPI AND THAT WAS THE GOAL OF THE SURGERY. THE MANUFACTURER'S REPRESENTATIVE DID NOT KNOW WHAT PROGRAMMING PARAMETERS WERE OR IF THEY AVOIDED CERTAIN CONTACTS AS THE HEALTHCARE PROFESSIONAL PROGRAMMED THE PATIENT. THE PATIENT HAD DIFFICULTY WITH SURGERIES SO THE HEALTHCARE PROFESSIONAL DIDN'T PLAN THEM LIGHTLY. THE DELAY OF BATTERIES AND LEAD IMPLANT WAS TO LET PT "REST" AND THE HEALTHCARE PROFESSIONAL WAS OUT OF TOWN FOR A WHILE. THERE WAS STILL POSSIBLY A PROBLEM WITH THE LEAD. IF ADDITIONAL INFORMATION IS REPORTED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83115 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1