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

Model Number D121

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Fluid Discharge (2686)

Event Date 02/13/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced hematoma with fluid discharges out of the pocket.The patient was admitted and given with a pocket pal to put pressure on the wound.Additional information was obtained which indicated that the physician opened the pocket, irrigated, treated, and closed.Furthermore, infection was not confirmed.The device 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.The returned device was thoroughly inspected and analyzed.Visual inspection found no irregularities that would have been present when the customer received or utilized the device, and the header was firmly attached.The device was successfully interrogated and completed a memory dump.The device operated appropriately, according to its performance specifications with no out of range measurements or interruptions in therapy output.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.

Event Description

It was reported that the patient with this implantable cardioverter defibrillator (icd) experienced hematoma with fluid discharges out of the pocket.The patient was admitted and given with a pocket pal to put pressure on the wound.Additional information was obtained which indicated that the physician opened the pocket, irrigated, treated, and closed.Furthermore, infection was not confirmed.The device remains in service.No additional adverse patient effects were reported.Additional information was obtained which indicated that the device was explanted.No additional adverse patient effects were reported.The product was returned for analysis.Device analysis determined that the device met specification and did not confirm the reported clinical observations.

• Brand Name: MOMENTUM EL ICD DR
• 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: 16453580
• MDR Text Key: 310356170
• Report Number: 2124215-2023-09334
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/25/2024
• Device Model Number: D121
• Device Catalogue Number: D121
• Device Lot Number: 236087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 02/28/2023
• Supplement Dates Manufacturer Received: 04/24/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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): Required Intervention; Hospitalization
• Patient Age: 60 YR
• Patient Sex: Male