MAUDE Adverse Event Report: MEDTRONIC, INC. Y ADAPTER CABLE; PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

Model Number	5103
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Arrhythmia (1721); Complete Heart Block (2627)
Date of Event	09/18/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that during the implant procedure, after the right ventricular (rv) lead was placed, testing of the lead was attempted using the analyzer and the adapter cables.Pacing was unable to be delivered to the patient while attempting to test the lead.The patient's heart dropped down to 17 beats per minute.This was resolved by plugging the lead directly into the implantable pulse generator (ipg).After inspecting the adapter cable, it was noted that the prongs had been damaged when it was plugged into the analyzer.The patient suffered arrhythmia and heart block.No further patient complications have been reported as a result of this event.

• Brand Name: Y ADAPTER CABLE
• Common Device Name: PULSE-GENERATOR, PACEMAKER, IMPLANTABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 9100774
• Report Number: 2182208-2019-01707
• Device Sequence Number: 19508234
• Product Code: DXY
• UDI-Device Identifier: 00643169838604
• UDI-Public: 00643169838604
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P890003
• 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): 09/20/2019

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: 5103
• Device Catalogue Number: 5103
• Device Lot Number: 695010001
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2019
• Initial Report FDA Received Date: 09/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 66 YR