MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN EL ICD DR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number D153

Device Problems Failure to Convert Rhythm (1540); Unexpected Therapeutic Results (1631); Under-Sensing (1661)

Patient Problem Electric Shock (2554)

Event Date 05/04/2023

Event Type  Injury  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) delivered unsuccessful anti-tachycardia pacing therapy for a polymorphic rhythm that was at a therapy zone.Afterwards, the device was charging a shock but apparently an external shock was delivered, and the rhythm was broken, therefore the icd charge was diverted due to a ventricular pace marker following.Throughout the episode there was some under sensed beats observed but therapy was not delayed due to this.Reprogramming options were discussed for this patient.The icd remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: DYNAGEN EL ICD DR
• Type of Device: IMPLANTABLE CARDIOVERTER 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: 17016270
• MDR Text Key: 316091563
• Report Number: 2124215-2023-26839
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534829
• UDI-Public: 00802526534829
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/19/2018
• Device Model Number: D153
• Device Catalogue Number: D153
• Device Lot Number: 204886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2016
• 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; Other
• Patient Age: 61 YR
• Patient Sex: Male