MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN EL ICD VR; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number D151

Device Problems Premature Discharge of Battery (1057); Device Displays Incorrect Message (2591)

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

Event Date 05/09/2022

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 implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed low voltage fault.Moreover, it was noted that the device hardware was not detecting any loss of battery energy hence the battery status indicators were not reflecting the depletion condition and were inaccurate.This should not be relied on to determined the depletion status of the device.Further, the device was malfunctioning and device replacement was recommended then return for detailed analysis.To date, the device remains in service.No adverse patient effects were reported.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned and analysis will be performed, a supplemental medwatch will be filed if there is any further relevant information from that review.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed low voltage fault.Moreover, it was noted that the device hardware was not detecting any loss of battery energy hence the battery status indicators were not reflecting the depletion condition and were inaccurate.This should not be relied on to determined the depletion status of the device.Further, the device was malfunctioning and device replacement was recommended then return for detailed analysis.To date, the device remains in service.No adverse patient effects were reported.Additional information indicated that the device was explanted due to a product performance anomaly.No additional adverse patient effects were reported.

Manufacturer Narrative

At this time, the product has not been returned.If the product is returned and analysis will be performed, a supplemental medwatch will be filed if there is any further relevant information from that review.The returned device was thoroughly inspected and analyzed.Review of device memory confirmed that a low voltage alert (code 1003) was recorded.A high current drain was detected, but the battery still supported full device function.Detailed analysis confirmed the identified high current drain was a result of compromised low voltage capacitors.Low voltage capacitors are used in the device's high voltage charging operation in order to facilitate fast charge times.Investigation has determined that the low voltage capacitors can become compromised due to the presence of excess hydrogen gas within the device case.Malfunction of these capacitors resulted in a high current drain, which was depleting this device's battery faster than normal.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) recorded a code 1003 indicative of battery voltage too low for the projected remaining capacity.Data analysis confirmed low voltage fault.Moreover, it was noted that the device hardware was not detecting any loss of battery energy hence the battery status indicators were not reflecting the depletion condition and were inaccurate.This should not be relied on to determined the depletion status of the device.Further, the device was malfunctioning and device replacement was recommended then return for detailed analysis.To date, the device remains in service.No adverse patient effects were reported.Additional information indicated that the device was explanted due to a product performance anomaly.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN EL ICD VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• 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: 14682734
• MDR Text Key: 293949222
• Report Number: 2124215-2022-20857
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534300
• UDI-Public: 00802526534300
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/20/2017
• Device Model Number: D151
• Device Catalogue Number: D151
• Device Lot Number: 190588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2015
• 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: 72 YR
• Patient Sex: Male