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

Model Number	2292
Medical Device Problem Code	Failure to Capture (1081)
Health Effect - Clinical Codes	Arrhythmia (1721); Seizures (2063)
Date of Event	05/23/2018
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 a device change procedure, a patient with complete heart block and no underlying escape rhythm, was disconnected from the old device and connected to the lead analyzer cables, which were connected to a programmer.Pacing spikes were evident on surface electrocardiogram (ecg), however, there were no signs of capture to follow.The lead and programmer connections were checked and were fine, however there was no change, even with very high outputs.It was noted that the patient had ventricular standstill and early signs of seizure.The new device was implanted without issue, and the cables were recommended to be returned for analysis, but the current status is unknown.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: analysis could not confirm the customer comment, the cable passed all visual inspection with no anomalies found.All continuity tests were ok.And no intermittent or shorted connections were found.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was further reported that the cables were returned to service.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7601199
• Report Number: 2182208-2018-01113
• Device Sequence Number: 16492868
• Product Code: KRG
• UDI-Device Identifier: 00643169703247
• UDI-Public: 00643169703247
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2018

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: 2292
• Device Catalogue Number: 2292
• Device Lot Number: ID1800054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 07/19/2018; 08/08/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 07/20/2018; 10/04/2018
• 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: 2090 PROGRAMMER, 229047 ANALYZER
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention