MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COGNIS; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number N118

Device Problems Over-Sensing (1438); Pacing Problem (1439); Device Sensing Problem (2917); High Capture Threshold (3266)

Patient Problems Non specific EKG/ECG Changes (1817); Occlusion (1984)

Event Date 01/01/2019

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) system exhibited noise, oversensing, and pacing inhibition on both the non-boston scientific right atrial (ra) and right ventricular (rv) leads.The pacing inhibition resulted in greater than 3 seconds of asystole.The oversensing resulted in inappropriate anti-tachycardia pacing (atp) being delivered.A review of the data showed that the number of ventricular episodes stored in the device over the last few weeks was significantly higher than in the prior months.Additionally, high threshold measurements were noted on the rv lead.The patient was admitted to the hospital and the crt-d was reprogrammed to cautery mode.The noise could not be recreated in office and other diagnostics appeared stable.The patient was scheduled for a device replacement procedure.During the procedure it was noted that the patient was occluded.The ra and rv leads were surgically abandoned and the physician elected to uncap an old rv lead that the patient had implanted.The crt-d was explanted and replaced.No additional adverse patient effects were reported.

• Brand Name: COGNIS
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8493714
• MDR Text Key: 141300932
• Report Number: 2124215-2019-03387
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S165
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/14/2010
• Device Model Number: N118
• Device Catalogue Number: N118
• Device Lot Number: 562939
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/15/2009
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 81 YR