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

Model Number D152

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Pocket Stimulation (1463); Device Sensing Problem (2917)

Patient Problem Muscle Stimulation (1412)

Event Date 09/12/2018

Event Type  malfunction  

Event Description

It was reported that this implantable cardioverter defibrillator (icd) and a non boston scientific right atrial (ra) lead exhibited oversensing of the minute ventilation (mv) signal.This resulted in inappropriate atrial tachy response (atr) mode switches.The patient felt stimulation which matched up with ventricular pacing while in atr mode switches.The ra impedance measurements at that time were between mid 500s to mid 800s ohms.The mv feature was programmed off.Additional information received reported that ra impedance measurements later increased to greater than 3000 ohms, and loss of capture was noted with threshold testing.The outputs were increased.No adverse patient effects were reported.

Manufacturer Narrative

This supplemental correction report is being filed to correct the report number in a previously submitted supplemental report (follow-up number 001) which was accepted by fda on 12/26/2018 02:01 pm ct.The report number is being corrected from: 2124215-2018-62683 to: 2124215-2018-62195.

Event Description

Additional information received reported that patient isometric troubleshooting was done which did not reproduce any noise, oversensing, or impedance changes.There were no other actions or interventions planned.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
• MDR Report Key: 8151888
• MDR Text Key: 130045213
• Report Number: 2124215-2018-62195
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 00802526534324
• UDI-Public: 00802526534324
• Combination Product (y/n): N
• PMA/PMN Number: P960040/S306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/08/2017
• Device Model Number: D152
• Device Catalogue Number: D152
• Device Lot Number: 508757
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR