MAUDE Adverse Event Report: MEDTRONIC, INC. ANALYZER CABLE; PROGRAMMER, PACEMAKER

Model Number	2292
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: four analyzer cables were returned and manufacturer's analysis was unable to confirm the customer comment that the analyzer cables weren't working properly.The four cables returned all passed incoming visual and functional testing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the customer had multiple analyzer cables which were not working properly, as the cables could not be used to measure signals on the atrial channel or ventricular and/or had noise on the atrial or ventricular channel.The cables were returned for analysis.There was no patient involvement.
Additional Manufacturer Narrative
Product analysis: analysis confirmed that one cable was not working correctly.It had bent pins and failed functional testing.The other cable passed all testing.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Two additional cables were returned.

• Brand Name: ANALYZER CABLE
• Common Device Name: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 7415709
• Report Number: 2182208-2018-00483
• Device Sequence Number: 16459719
• Product Code: KRG
• UDI-Device Identifier: 00643169703247
• UDI-Public: 00643169703247
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P890003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/25/2018

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: 2292
• Device Catalogue Number: 2292
• Device Lot Number: 631930001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Initial Date Received by Manufacturer: 01/12/2018
• Supplement Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/10/2018
• Supplement Report FDA Received Date: 04/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1