Class 2 Device Recall St. Jude Medical Infinity DBS System, 8Channel Directional Leads

• Date Initiated by Firm: October 11, 2018
• Create Date: December 10, 2018
• Recall Status: Terminated on September 13, 2022
• Recall Number: Z-0593-2019
• Recall Event ID: 81461
• PMA Number: P140009S001 P140009S037
• Product Classification: Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
• Product: St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 30 cm, 0.5 REF 6170 - STERILE EO Rx ONLY; CE 0086 0123; St. Jude Medical; Plano, TX; ; St. Jude Medical InfinityTM DBS System 8CH Directional Lead, 40 cm, 0.5 REF 6172 STERILE EO Rx ONLY; St. Jude Medical; Plano, TX; ; Instructions For Use: Lead and Extension Kits; for Deep Brain Stimulation Systems Clinician's Manual; ST. JUDE MEDICAL - Product Usage: St. Jude Medical Deep Brain Stimulation (DBS)leads are intended to deliver stimulation to target areas in the brain. DBS extensions are intended to connect the leads to implantable pulse generators (IPGs). St. Jude Medical DBS leads are designed for introduction into the brain using standard stereotactic neurosurgical techniques. DBS system delivers electrical stimulation to a precisely targeted area in the brain. Leads are implanted in the brain and are connected to extensions, which are passed under the skin and are connected to the neurostimulator. Leads for the St. Jude Medical Infinity DBS System feature electrodes on a stiff distal end with an inactive lead tip. The proximal end of the lead contains contact bands that correspond with each of the distal electrodes and an inactive band that functions as a contact for a setscrew when connecting to a compatible extension. The 8-channel leads contain cylindrical and segmented electrodes. The segmented electrodes can be activated independently to focus stimulation in one direction to help target desired neurological structures. As stated in Clinician manual (ARTEN600008305 Rev A), leads materials which are intended to come into contact with tissue are Platinum-iridium and polycarbonate urethane. In addition, drawing for the Stim Tip, 1-3-3-1 Directional DBS lead requires that the electrode material shall be 90/10 Platinum Iridium.
• Code Information: For Model 6170ANS: UDI/GTIN - 05415067020635 / 05415067030306 US: Serial Numbers Lot Number 17277045 6351121 OUS: 17145460 6244627 17149644 6262443 17149652 6262443 17149625 6262443 17149630 6262443 17149631 6262443 17149647 6262443 17149650 6262443 17149653 6262443 17168532 6272675 17168533 6272675 17168534 6272675 17168541 6272675 17145439 6244627 17145459 6244627 17145461 6244627 17145463 6244627 17113441 6212647 17113442 6212647 17113445 6212647 17145451 6244627 17113436 6212647 17145454 6244627 17145458 6244627 17145438 6244627 17145446 6244627 17145448 6244627 17145453 6244627 17145457 6244627 17145462 6244627 17166635 6272679 17113438 6212647 17149635 6262443 17149641 6262443 17149655 6262443 17166627 6272679 17149629 6262443 17149633 6262443 17149637 6262443 17149645 6262443 17149646 6262443 17149626 6262443 17149654 6262443 17145447 6244627 17145456 6244627 17215431 6299732 17215434 6299732 17215455 6299732 17113440 6212647 17113447 6212647 17149624 6262443 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17277043 6351121 17277047 6351121 17277048 6351121 17277054 6351121 17277058 6351121 17277062 6351121 17277069 6351121 17309335 6371714 17309341 6371714 17309344 6371714 17309350 6371714 17309356 6371714 17309362 6371714 17338050 6391795 17338052 6391795 17338053 6391795 17338054 6391795 17338057 6391795 17338058 6391795 17338059 6391795 17338060 6391795 17338064 6391795 For Model 6172ANS: UDI/GTIN - 05415067020680 / 05415067030320 US: Serial Numbers Lot Number 17101268 6212648 17101271 6212648 17101279 6212648 17101281 6212648 17101282 6212648 17101285 6212648 17101288 6212648 17101292 6212648 17101294 6212648 17101297 6212648 17101298 6212648 17101301 6212648 17101302 6212648 17101315 6212648 17101316 6212648 17101318 6212648 17101322 6212648 17101307 6212648 17101296 6212648 17101293 6212648 17101304 6212648 17145561 6244642 17145539 6244642 17145542 6244642 17145549 6244642 17158024 6262459 17158016 6262459 17158029 6262459 17174775 6272706 17174765 6272706 17174762 6272706 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• Recalling Firm/ Manufacturer: St. Jude Medical, Inc.; 6901 Preston Rd; Plano TX 75024-2508
• For Additional Information Contact: Justin Paquette; 651-756-6293
• Manufacturer Reason for Recall: The most proximal unsegmented electrode of the Deep Brain Stimulation leads, may be constructed with MP35N instead of the required 90/10 platinum-iridium.
• FDA Determined Cause: Mixed-up of materials/components
• Action: On October 11, 2018, the firm sent an Urgent Medical Device Recall Notice to customers (i.e, Hospital Administrators) via overnight mail service informing them that the firm's records indicate that the institution has/had received the affected 8-Channel Lead that may be impacted by an isolated manufacturing issue. The notification explains that the firm believes that some of the listed leads may contain an electrode that does not conform to material specification. In total, there have been four (4) reports from (2) centers describing that the most proximal stimulation tip electrode (electrode position 4) appeared lighter than the more distal electrodes when radiographed. There have been no reports of patient harm to date. Further communication with additional details about this action, inclusive of management recommendations for any patients that may have been implanted with an affected lead, will be forthcoming as soon as possible. The notification also informs the customer that the firm's representative will assist with removing these leads from the customer's account and will facilitate replacing them. The firm is requesting the customer's support on the removal and return of these leads. The FDA has been notified of this activity. In the meantime, if hospitals or it's physicians have any questions, they can contact their local Sales Representative or Abbott Support at 1-800-727-7846 (Opt3). Customers were also provided with an Acknowledgement Form and instructed to complete all requested information and to return immediately. The Acknowledgement Form included a list of the models and serial numbers of the devices that have been delivered to the facilities, but that records do not yet reflect an implant. The customer is instructed to review and indicate if the device(s) were removed or implanted. Customer are instructed to please return the Acknowledgement Form to Abbott at email: DBSNotices@Abbott.com. On October 29, 2018, the firm sending out
• Distribution: Worldwide distribution - US nationwide distribution in the states of AZ, CA, CO, FL, GA, IL, MD, MN, MO, MT, NC, NJ, NY, OH, PA, and WA. International distribution in the countries of Argentina, Australia, Austria, Belgium, Brazil, Colombia, Czech Republic, Finland, France, Germany, Hungary, Italy, Mexico, Poland, Russian Federation, Saudi Arabia, South Korea, Spain, Sweden, Taiwan, Turkey, and United Kingdom
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• PMA Database: PMAs with Product Code = MHY and Original Applicant = Abbott Medical