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

Model Number	5833SL
Medical Device Problem Codes	Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the complaint was confirmed; positive connection continuity tests on the cable measured open.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that device testing was unable to be performed using this cable.A different cable was able to be used with no issue.The cable was returned.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: 7516706
• Report Number: 2182208-2018-00913
• Device Sequence Number: 11119185
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2018

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 Model Number: 5833SL
• Device Catalogue Number: 5833SL
• Device Lot Number: 663970001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2018
• Initial Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR