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

Model Number D152

Device Problems Pacing Problem (1439); Under-Sensing (1661); Data Problem (3196)

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

Event Date 02/27/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the patient implanted with this implantable cardioverter defibrillator (icd) typically had atrial pacing with ventricular sensing, or ap vs.But whenever a premature ventricular contraction (pvc) occurred, the device started pacing and av conduction was not re-established.Programming assistance was requested, and the field representative noted that avsearchhysteresis (avsh) was off at the time.Review of a-a and v-v timing showed conduction was approximately 240 ms, and once a pvc occurred the device began av pacing.Avsh did not appear to be programmed off, as the first av interval was longer than the preceding av interval.The subsequent ap was likely delivered into refractory tissue, thus did not capture.Additionally, the patient blocked at rates above 100.Technical services (ts) recommended decreasing the lower rate limit (lrl) to 60 beats per minute (bpm) from 70 bpm and decreasing the avsh interval to 300-330 ms from 400 ms.There was also discussion about enabling atrial flutter response (afr).This icd remains in service.No adverse patient effects were reported.

• Brand Name: DYNAGEN 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: 18918849
• MDR Text Key: 337844302
• Report Number: 2124215-2024-15964
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534324
• UDI-Public: 00802526534324
• 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
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 06/18/2017
• Device Model Number: D152
• Device Catalogue Number: D152
• Device Lot Number: 504475
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2015
• 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 Age: 47 YR
• Patient Sex: Female