MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COGNIS; IMPLANTABLE DEFIBRILLATOR

Model Number P108

Device Problems Device Alarm System (1012); High impedance (1291); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/22/2022

Event Type  malfunction  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) emitted audible tones.Upon the evaluation of the device it was noted that it exhibited high out of range pacing impedance measurements on right atrial (ra) channel, aside from that, all other measurements were within normal limits.It was decided to perform a lead and device replacement in the near future.Two months later the device emitted audible tones once again, however this time, the function for the device to emit tones was turned off, therefore, the cause for the sounds could not be determined, no changes have been performed since the plan continues to be replacing the device and lead.This device remains in service.No further adverse patient effects were reported.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) emitted audible tones.Upon the evaluation of the device it was noted that it exhibited high out of range pacing impedance measurements on right atrial (ra) channel, aside from that, all other measurements were within normal limits.It was decided to perform a lead and device replacement in the near future.Two months later the device emitted audible tones once again, however this time, the function for the device to emit tones was turned off, therefore, the cause for the sounds could not be determined, no changes have been performed since the plan continues to be replacing the device and lead.This device remains in service.No further adverse patient effects were reported.

Manufacturer Narrative

This product has not been returned to boston scientific, and as a result, laboratory analysis could not be conducted.The associated investigation determined that this device exhibited intermittent fluctuations in impedance measurements with no conclusive evidence of a product malfunction; please refer to the complaint description for more information regarding the specific circumstances of this event.

• Brand Name: COGNIS
• Type of Device: IMPLANTABLE DEFIBRILLATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14918851
• MDR Text Key: 295311268
• Report Number: 2124215-2022-24260
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/13/2012
• Device Model Number: P108
• Device Catalogue Number: P108
• Device Lot Number: 104216
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2011
• 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 Age: 43 YR
• Patient Sex: Female