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

Model Number D150

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Convert Rhythm (1540); Unexpected Therapeutic Results (1631)

Patient Problems Arrhythmia (1721); Electric Shock (2554)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that this system with an implantable cardioverter defibrillator (icd) and a right ventricular (rv) lead had been showing high, shock impedances that have been in the limit for out-of-range values.The device had never delivered a shock.A defibrillation threshold (dft) test was initiated.The first two delivered shocks were unsuccessful to convert.After the second shock was delivered an error message 1005, related to open circuit, was triggered.The rv was recommended to be replaced.The icd was recommended to be evaluated as well to check integrity.The rv and icd remain in service at ths time.No additional adverse patient effects were reported.

Event Description

It was reported that this system with an implantable cardioverter defibrillator (icd) and a right ventricular (rv) lead had been showing high, shock impedances that have been in the limit for out-of-range values.The device had never delivered a shock.A defibrillation threshold (dft) test was initiated.The first two delivered shocks were unsuccessful to convert.After the second shock was delivered an error message 1005, related to open circuit, was triggered.The rv was recommended to be replaced.The icd was recommended to be evaluated as well to check integrity.According to the field representative, the physician ordered to turn therapies off.The patient was discharged, a possible lead extraction and s-icd implant was considered but the field representative was not aware of a scheduled procedure for the patient.The rv and icd remain in service at this time.No additional adverse patient effects were reported.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

It was reported that this system with an implantable cardioverter defibrillator (icd) and a right ventricular (rv) lead had been showing high, shock impedances that have been in the limit for out-of-range values.The device had never delivered a shock.A defibrillation threshold (dft) test was initiated.The first two delivered shocks were unsuccessful to convert.After the second shock was delivered an error message 1005, related to open circuit, was triggered.The rv was recommended to be replaced.The icd was recommended to be evaluated as well to check integrity.According to the field representative, the physician ordered to turn therapies off.The patient was discharged, a possible lead extraction and s-icd implant was considered but the field representative was not aware of a scheduled procedure for the patient.The rv and icd remain in service at this time.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN EL ICD VR
• 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: 16974022
• MDR Text Key: 315736660
• Report Number: 2124215-2023-25306
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534287
• UDI-Public: 00802526534287
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/07/2019
• Device Model Number: D150
• Device Catalogue Number: D150
• Device Lot Number: 224271
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2017
• 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; Required Intervention
• Patient Age: 41 YR
• Patient Sex: Female