MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESONATE HF CRT-D; CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)

Model Number G547

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Unexpected Therapeutic Results (1631); Low impedance (2285)

Patient Problems Pain (1994); Discomfort (2330); Confusion/ Disorientation (2553)

Event Date 12/15/2023

Event Type  Injury  

Event Description

It was reported that, the patient with this cardiac resynchronization therapy defibrillator (crt-d) exhibited a cardiac arrest.The first shock converted the rhythm nonetheless, patient went back into arrhythmia.Then, the subsequent shock exhibited low shock impedances out of range and subsequent attempts had charge times of 0.0 sec.The crt-d was interrogated and got a code 1004 indicative of a short circuit condition during shock delivery.The patient had gotten external shocks and cardiopulmonary resuscitation (cpr).Technical services (ts) recommended to replace this crt-d and the right ventricular (rv) lead.No additional adverse patient effects were reported.

Event Description

It was reported that, the patient with this cardiac resynchronization therapy defibrillator (crt-d) exhibited a cardiac arrest.The first shock converted the rhythm nonetheless, patient went back into arrhythmia.Then, the subsequent shock exhibited low shock impedances out of range and subsequent attempts had charge times of 0.0 sec.The crt-d was interrogated and got a code 1004 indicative of a short circuit condition during shock delivery.The patient had gotten external shocks and cardiopulmonary resuscitation (cpr).Technical services (ts) recommended to replace this crt-d and the right ventricular (rv) lead.No additional adverse patient effects were reported.Additional information was received which indicated that, this crt-d was explanted and replaced.The patient was reported to be in pain and in discomfort.No additional adverse patient effects were reported.

Event Description

It was reported that, the patient with this cardiac resynchronization therapy defibrillator (crt-d) exhibited a cardiac arrest.The first shock converted the rhythm nonetheless, patient went back into arrhythmia.Then, the subsequent shock exhibited low shock impedances out of range and subsequent attempts had charge times of 0.0 sec.The crt-d was interrogated and got a code 1004 indicative of a short circuit condition during shock delivery.The patient had gotten external shocks and cardiopulmonary resuscitation (cpr).Technical services (ts) recommended to replace this crt-d and the right ventricular (rv) lead.No additional adverse patient effects were reported.Additional information was received which indicated that, this crt-d was explanted and replaced.The patient was reported to be in pain and in discomfort.No additional adverse patient effects were reported.

Manufacturer Narrative

The returned device was thoroughly inspected and analyzed.The device was able to be interrogated and a memory download was performed.It was noted a shock lead shorted code recorded.This was followed by several hi voltage during charge repeat codes.High power visual inspection did not find any evidence of an arc mark.Real time x-ray noted that the plasma fuse was open and with an open plasma fuse the pacemaker cannot charge the high voltage capacitors.Analysis identified device characteristics that would have caused or contributed to the reported clinical observations.

• Brand Name: RESONATE HF CRT-D
• Type of Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
• 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: 18379992
• MDR Text Key: 331178859
• Report Number: 2124215-2023-73157
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589744
• UDI-Public: 00802526589744
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S436
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/27/2023
• Device Model Number: G547
• Device Catalogue Number: G547
• Device Lot Number: 266580
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Male