MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC CABLE; PULSE-GENERATOR, PACEMAKER, EXTERNAL

Model Number MDT-CABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Date 03/18/2022

Event Type  Injury  

Event Description

It was reported that the external pulse generator (epg) inappropriately fired on the incorrect portion of the patient's waveform.It was noted that the issue was experienced after the patient cables were plugged into the epg when the patient's heart rate began to fluctuate between high seventies and low eighties.It was also noted that the ventricular wires were being used for pacing as the atrial wires had failed and further that the ventricular wires had not properly captured when they were tested in the operating room during placement and had been turned off.It was further noted that the ventricular wires were set to pace at eighty beats per minute as the patient's heart rate could drop to the seventies.It was noted that the patient cables were left disconnected from the epg and the user had been instructed to only connect the patient cables if the heart rate was sustained below eighty.It was further noted that the patient went into torsades de pointes and required cardiopulmonary resuscitation.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

• Brand Name: MEDTRONIC CABLE
• Type of Device: PULSE-GENERATOR, PACEMAKER, EXTERNAL
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 15482706
• MDR Text Key: 300565007
• Report Number: 2182208-2022-03036
• Device Sequence Number: 1
• Product Code: DTE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MDT-CABLE
• Device Catalogue Number: MDT-CABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/01/2022
• 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
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 24 DA
• Patient Sex: Female