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

Model Number D152

Device Problems High impedance (1291); Failure to Sense (1559)

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

Event Date 01/05/2024

Event Type  Injury  

Event Description

It was reported that the right atrial (ra) lead of this implantable cardioverter defibrillator (icd) system was suspected to be fractured.High out of range impedance measurements were observed as well.A revision procedure was performed and when attempting to get sensing, this device did not sense the newly implanted atrial lead.The lead was unplugged and sensing was evaluated with the pacing system analyzer (psa) and normal measurements were obtained.The lead was connected to a new device and normal device function was observed.The physician could not determine if the atrial lead was fractured or if it was a device issue.No additional adverse patient effects were reported.It is expected to receive this device for analysis.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed upon receipt at our post market quality assurance laboratory.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.Analysis found no evidence of device defect, malfunction, or damage outside the bounds of normal medical use.

Event Description

It was reported that the right atrial (ra) lead of this implantable cardioverter defibrillator (icd) system was suspected to be fractured.High out of range impedance measurements were observed as well.A revision procedure was performed and when attempting to get sensing, this device did not sense the newly implanted atrial lead.The lead was unplugged and sensing was evaluated with the pacing system analyzer (psa) and normal measurements were obtained.The lead was connected to a new device and normal device function was observed.The physician could not determine if the atrial lead was fractured or if it was a device issue.No additional adverse patient effects were reported.This device has been received for analysis.

• 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: 18567467
• MDR Text Key: 333535650
• Report Number: 2124215-2024-03491
• Device Sequence Number: 1
• Product Code: LWS
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/22/2021
• Device Model Number: D152
• Device Catalogue Number: D152
• Device Lot Number: 559962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2019
• 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: 54 YR
• Patient Sex: Male