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

Model Number D152

Device Problems High impedance (1291); Incorrect, Inadequate or Imprecise Result or Readings (1535); Low impedance (2285)

Patient Problem Shock (2072)

Event Date 05/31/2022

Event Type  malfunction  

Manufacturer Narrative

Device remains implanted.As such, physical analysis has not been conducted in our laboratory.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that this implantable cardioverter defibrillator (icd) device, exhibited chronic high shock impedance (greater than 140 ohms) and decreasing pacing impedance from 750 ohms to 450 ohms.The device delivered 6 shocks and triggered a code 1005.A technical service (ts) reviewed device data and provided recommendation of a device and lead revision in the near future.The device remains implanted.Attempts to obtain additional information and lead model/serials have been unsuccessful.The boston scientific representative advised that the patient transferred themselves to a different facility.

• 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: 15551596
• MDR Text Key: 303438762
• Report Number: 2124215-2022-40074
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534324
• UDI-Public: 00802526534324
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/17/2017
• Device Model Number: D152
• Device Catalogue Number: D152
• Device Lot Number: 501984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2022
• Initial Date FDA Received: 10/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1