MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAGEN X4 CRT-D; DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D

Model Number G156

Device Problems High impedance (1291); Pacing Problem (1439); Failure to Convert Rhythm (1540); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Displays Incorrect Message (2591)

Patient Problems Atrial Fibrillation (1729); Ventricular Tachycardia (2132)

Event Date 11/14/2018

Event Type  Injury  

Event Description

It was reported that this cardiac resynchronization therapy defibrillator (crt-d) delivered multiple inappropriate shocks due to atrial fibrillation with rapid ventricular response.The crt-d declared code 1005, which indicates an open circuit was detected during shock delivery.The right ventricular (rv) lead exhibited high out of range shock impedances, measuring greater than 125 ohms.Data analysis showed the patient received 2 inappropriate anti-tachycardia pacing (atp) therapies, and 6 inappropriate shocks.The rv lead impedances on all 6 shocks were greater than 125 ohms.After this episode, there 5 inappropriate atrial tachy response (atr) therapies and 6 additional inappropriate shocks.The rv lead impedances were within normal range on these 6 shocks.It was noted none of the shocks converted the patient's rhythm, and the rv lead pacing impedances had decreased.Boston scientific technical services (ts) discussed that the shock impedances may have lowered due to deposit built up on the coils, which was cleaned off during the shocks.Subsequently a revision procedure was performed.The rv lead was surgically abandoned and replaced.The crt-d remains in service.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN X4 CRT-D
• Type of Device: DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CRT-D
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CLONMEL LIMITED; cashel road; ,; clonmel ; EI
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 8180076
• MDR Text Key: 130873978
• Report Number: 2124215-2018-62264
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534669
• UDI-Public: 00802526534669
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2018

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2018
• Device Model Number: G156
• Device Catalogue Number: G156
• Device Lot Number: 374525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2016
• 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; Life Threatening; Required Intervention
• Patient Age: 69 YR