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

Model Number	3013
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
During processing of this incident, attempts were made to obtain complete physician information.Date of event is estimated.
Event or Problem Description
It was reported that a demo trial cable was used in a case.
Additional Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined. .

• Brand Name: MULTILEAD TRIAL CABLE
• Common Device Name: SCS TRIAL LEAD CABLE
• 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: 12570523
• Report Number: 3008377825-2021-00013
• Device Sequence Number: 17120612
• Product Code: LGW
• UDI-Device Identifier: 05414734405355
• UDI-Public: 05414734405355
• Combination Product (Y/N): N
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: 3013
• Device Catalogue Number: 3013
• Device Lot Number: P000117481
• 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: 09/15/2021
• Supplement Date Received by Manufacturer: 10/27/2021
• Initial Report FDA Received Date: 10/04/2021
• Supplement Report FDA Received Date: 11/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown