MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC CRT-P; PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION

Model Number MDT-CRT-P

Device Problems Pacing Problem (1439); Unable to Obtain Readings (1516)

Patient Problems Syncope (1610); Atrial Fibrillation (1729); Tachycardia (2095)

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 sustained atrial arrhythmia and was not paced for twenty minutes.The patient states that the device did not record this event or other events when they "pass out, suffer atrial fibrillation and tachycardia".The device remains in use.No further patient complications have been reported as a result of this event.

• Brand Name: MEDTRONIC CRT-P
• Type of Device: PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION
• 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: 9488868
• MDR Text Key: 174357401
• Report Number: 2182208-2019-02314
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MDT-CRT-P
• Device Catalogue Number: MDT-CRT-P
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/23/2019
• 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
• Patient Outcome(s): Life Threatening