MAUDE Adverse Event Report: ST. JUDE MEDICAL OPERATIONS (M) SDN BHD MULTILEAD TRIAL CABLE; LEAD ACCESSORY

Model Number	3013
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Use of product past product expiration date was confirmed.Product was used in a case on friday (b)(6) 2022, whereas product expiration was 31jul2021.Based on the review of the complaint, the method used to assign ubd for the product, sterile barrier testing performed, the overall performance of the device, intended use of the device, low probability of occurrence and worst-case risk assessment detailed above, the patient risk for use of a device passed the ubd is occasional.The inventory procedure update to implement device check was not released at the time of procedure.Since the occurrence, the inventory management policy (b)(4), rev g was released on 03-feb-2022.No reports of patient adverse impacts.No further action outside of completion of capa (b)(4) planned activities is needed.
Event or Problem Description
It was reported that an expired mltc cable was used during the patient's implant procedure.Procedure was completed with no complications.No additional information is known at this time.

• Brand Name: MULTILEAD TRIAL CABLE
• Common Device Name: LEAD ACCESSORY
• Manufacturer (Section D): ST. JUDE MEDICAL OPERATIONS (M) SDN BHD; plot 102, lebuhraya kampung jawa; bayan lepas industrial zone; penang, pulau pinang 11900 ; MY 11900
• Manufacturer (Section G): ST. JUDE MEDICAL OPERATIONS (M) SDN BHD; plot 102, lebuhraya kampung jawa; bayan lepas industrial zone; penang, pulau pinang 11900 ; MY 11900
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 13935543
• Report Number: 3008377825-2022-00005
• Device Sequence Number: 4132186
• Product Code: LGW
• UDI-Device Identifier: 05414734405355
• UDI-Public: 05414734405355
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: 3013
• Device Catalogue Number: 3013
• Device Lot Number: P000084041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/03/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 51 YR
• Patient Sex: Male