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

Model Number 2292

Device Problem Failure to Capture (1081)

Patient Problems Arrhythmia (1721); Seizures (2063)

Event Date 05/23/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event 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.

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 Description

It was further reported that the cables were returned to service.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ANALYZER CABLE
• Type of Device: PROGRAMMER, PACEMAKER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7601199
• MDR Text Key: 111050517
• Report Number: 2182208-2018-01113
• Device Sequence Number: 1
• Product Code: KRG
• UDI-Device Identifier: 00643169703247
• UDI-Public: 00643169703247
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P890003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: 2090 PROGRAMMER, 229047 ANALYZER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 94 YR