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

Model Number D121

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Therapeutic Results (1631)

Patient Problem Fall (1848)

Event Date 02/22/2023

Event Type  Injury  

Event Description

It was reported that the patient with this system with an implantable cardioverter defibrillator (icd), right ventricular (rv) and right atrial (ra) leads fell to the ground.A shock was delivered but a fault code 1004 related to short circuit was triggered.Also, a code 1006 regarding high voltage was triggered afterwards.External shocks were needed to convert the arrhythmia the patient was experiencing.The icd, ra and rv leads have been explanted 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

Upon receipt at our post market quality assurance laboratory, visual inspection of the device identified no anomalies.Review of device memory found a shorted lead error code 1004 and 1006 had been recorded.Memory also showed that after three shocks had been attempted and resulted in abnormal shock impedance measurements.An x-ray of the device revealed that the internal high voltage fuse was damaged (i.E., no longer intact).The damage to the fuse most likely occurred during delivery of the shock that resulted in the shorted lead error.The damage to the high voltage fuse prevented any subsequent charging of the high voltage capacitors and delivery of shock therapy.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient with this system with an implantable cardioverter defibrillator (icd), right ventricular (rv) and right atrial (ra) leads fell to the ground.A shock was delivered but a fault code 1004 related to short circuit was triggered.Also, a code 1006 regarding high voltage was triggered afterwards.External shocks were needed to convert the arrhythmia the patient was experiencing.The icd, ra and rv leads have been explanted at this time.No additional adverse patient effects were reported.

• Brand Name: MOMENTUM 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: 16551323
• MDR Text Key: 311369105
• Report Number: 2124215-2023-12405
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526587726
• UDI-Public: 00802526587726
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/14/2024
• Device Model Number: D121
• Device Catalogue Number: D121
• Device Lot Number: 233157
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• 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: 63 YR
• Patient Sex: Male