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

Model Number G151

Device Problems Premature Discharge of Battery (1057); High impedance (1291); Battery Problem (2885); High Capture Threshold (3266)

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

Event Date 06/15/2023

Event Type  Injury  

Event Description

It was reported that this right ventricular (rv) lead was surgically abandoned and replaced due to elevated thresholds, and the right atrial (ra) lead was explanted due to high out-of-range pace impedance measurements greater than 3,000 ohms.Review of remote monitoring data showed no evidence of noise.Rv pacing thresholds were 3.4v @ 1.0ms and rv output was set to 4v @1ms, which resulted in the battery depleting faster than expected.The cardiac re-synchronization therapy defibrillator (crt-d) was also explanted and replaced during the same procedure.It was noted that the ra lead was not replaced and the new device was programmed to vvir because the patient was in chronic atrial fibrillation (af).No additional adverse patient effects were reported.

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The local area field representative was contacted for additional information.If information is provided in the future, a supplemental report will be issued.If pertinent information is provided in the future, a supplemental report will be submitted.

Event Description

It was reported that this right ventricular (rv) lead was surgically abandoned and replaced due to elevated thresholds, and the right atrial (ra) lead was explanted due to high out-of-range pace impedance measurements greater than 3,000 ohms.Review of remote monitoring data showed no evidence of noise.Rv pacing thresholds were 3.4v @ 1.0ms and rv output was set to 4v @1ms, which resulted in the battery depleting faster than expected.The cardiac resynchronization therapy defibrillator (crt-d) was also explanted and replaced during the same procedure.It was noted that the ra lead was not replaced and the new device was programmed to vvir because the patient was in chronic atrial fibrillation (af).No additional adverse patient effects were reported.Additional information received reported that during the revision procedure, pacing system analyzer (psa) testing was performed on the right atrial (ra) and right ventricular (rv) lead.Ra pace impedance measurements were greater than 3,000 ohms and rv thresholds were greater than 3.5v @ 1ms.No additional adverse patient effects were reported.The explanted products will not be returned as they were discarded by the explanting facility.

• Brand Name: DYNAGEN CRT-D
• 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 CORPORATION; cashel road; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 17224051
• MDR Text Key: 318074285
• Report Number: 2124215-2023-33890
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534638
• UDI-Public: 00802526534638
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/03/2021
• Device Model Number: G151
• Device Catalogue Number: G151
• Device Lot Number: 133131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2019
• 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): Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male