MAUDE Adverse Event Report: UNKNOWN DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

Patient Problems Failure of Implant (1924); Dizziness (2194)

Event Type  Injury  

Event Description

It was reported that patient presented with dizziness and was found to have multiple episodes of ventricular pauses.An interrogation showed significant noise on the competitor right ventricular (rv) lead that resulted in inhibition of pacing.A venogram showed occlusion of the left sub-clavicular vein with quick resumption of the vein just medial to the first rib.The patient was referred for either rv lead replacement or reassessment of the setscrew.During the replacement procedure, the cardiac resynchronization therapy pacemaker (crt-p) was removed from the pocket, visually the rv lead was detached from the device and did not appear to be a setscrew issue.Normal function was noted when the leads were tested.The rv lead was manipulated which did not show noise.The rv lead was then plugged into the atrial port and device manipulation did result in inhibition of pacing.Therefore, it was initially thought the rv lead fractured.A new rv lead was implanted and attached to the device, noise and inhibition of pacing was noted.It was thought there was a device malfunction and a new crt-p was used.The leads were attached to the new device, however, manipulation resulted in inhibition of pacing.It was discovered that the competitor left ventricular (lv) lead was in the rv port, and thus the lv lead was the fractured lead.When the leads were properly placed in the device, no inhibition of pacing was noted.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).Reference reports: #mw5147567, #mw5147568.

• Brand Name: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18046905
• MDR Text Key: 327352673
• Report Number: MW5147569
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 10/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1