MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0672

Device Problems Signal Artifact/Noise (1036); Failure to Capture (1081); Low impedance (2285); Device Dislodged or Dislocated (2923); High Capture Threshold (3266)

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

Event Date 03/24/2024

Event Type  Injury  

Event Description

It was reported that the implantable cardioverter defibrillator (icd) alerted for right ventricular automatic threshold detected as > programmed amplitude or suspended due to intrinsic beats and noise.Capture cannot be confirmed on the presenting electrogram (egm) due to intrinsic conduction.Further review in-clinic was recommended for reassessing threshold.At this time the device and this recently implanted right ventricular (rv) lead remain in service.Received additional information this rv lead appears to be dislodged.The pacing impedance has dropped, and the threshold has increased.The physician elected to deactivate the icd therapies and a lead revision has been scheduled.At this time, the lead remains in service.No adverse patient effects were reported.

Event Description

It was reported that the implantable cardioverter defibrillator (icd) alerted for right ventricular automatic threshold detected as > programmed amplitude or suspended due to intrinsic beats and noise.Capture cannot be confirmed on the presenting electrogram (egm) due to intrinsic conduction.Further review in-clinic was recommended for reassessing threshold.At this time the device and this recently implanted right ventricular (rv) lead remain in service.Received additional information this rv lead appears to be dislodged.The pacing impedance has dropped, and the threshold has increased.The physician elected to deactivate the icd therapies and a lead revision has been scheduled.At this time, the lead remains in service.No adverse patient effects were reported.Additional information received advised the rv lead has been explanted and replaced successfully.Satisfactory lead parameters were obtained with the new lead.The explanted lead will not return for analysis.Outside of the revision, no adverse patient effects were reported.

• Brand Name: RELIANCE 4-FRONT
• 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; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 19056118
• MDR Text Key: 339547708
• Report Number: 2124215-2024-20949
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/01/2024

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 Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 235172
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/26/2024
• Initial Date FDA Received: 04/05/2024
• Supplement Dates Manufacturer Received: 04/10/2024
• Supplement Dates FDA Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2023
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Female