MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC LEAD; IMPLANTABLE PACEMAKER PULSE-GENERATOR

Model Number MDT-LEAD

Device Problems Failure to Capture (1081); Fracture (1260); Pacing Problem (1439); Connection Problem (2900)

Patient Problems Arrhythmia (1721); Bradycardia (1751)

Event Date 03/18/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, the patient experienced torsades de pointes and sustained bradycardia.It was also reported that the right ventricular (rv) lead did not properly capture from insertion and hence, was initially programmed off.Subsequently, the rv lead "fell out," of the cable receptacles and was fractured.The rv lead was repaired and on re-insertion to the patient's cable receptacle and turning the connector knob, the pacemaker paced on the patient's t-wave resulting in torsades de pointes.Cardiopulmonary resuscitation was required.Within the next six weeks, the right atrial (ra) lead failed, where it "fell out," of the cable receptacles and was fractured, and the patient had to rely on rv lead pacing, when required.The leads were disconnected from the cables and the patient was monitored for pacing requirements.Subsequently the patient developed sustained bradycardia and on re-connection of the generator, the pacemaker paced on the t-wave resulting again in torsades de pointes.Cardiopulmonary resuscitation was again required.Approximately two months later, both the rv lead and ra lead were replaced.No further patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC LEAD
• Type of Device: IMPLANTABLE PACEMAKER PULSE-GENERATOR
• 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: 15491489
• MDR Text Key: 300698489
• Report Number: 2182208-2022-03050
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/26/2022

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
• Device Operator: Lay User/Patient
• Device Model Number: MDT-LEAD
• Device Catalogue Number: MDT-LEAD
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MDT LEAD, 5392 EPG, MDT-CABLE
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 24 DA
• Patient Sex: Female