MAUDE Adverse Event Report: MEDTRONIC, INC.; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	5833SL
Medical Device Problem Codes	No Device Output (1435); Device Sensing Problem (2917); Inadequate User Interface (2958); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Analysis summary: analysis confirmed the customer comment of a seemingly malfunctioning cable, its negative continuity tests measured "open".If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that heart rhythm tracings (intercardiac) were unable to be obtained when the cable was in use and that the cable was unable to pace.The cable was returned to service.No patient complications have been reported as a result of this event.

• Brand Name: NA
• Common Device Name: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7605750
• Report Number: 2182208-2018-01127
• Device Sequence Number: 16618846
• Product Code: LDF
• UDI-Device Identifier: 00681490136365
• UDI-Public: 00681490136365
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K923407
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/15/2018

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5833SL
• Device Catalogue Number: 5833SL
• Device Lot Number: 664870001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2018
• Initial Report FDA Received Date: 06/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 383069 LEAD,
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR