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

Model Number 0692

Device Problems Failure to Capture (1081); Pocket Stimulation (1463); High Capture Threshold (3266)

Patient Problem Muscle Stimulation (1412)

Event Date 10/21/2018

Event Type  Injury  

Manufacturer Narrative

No additional information is available.If additional information becomes available, this report will be updated at that time.

Event Description

It was reported that this right ventricular (rv) lead displayed loss of capture.Technical services reviewed the electrogram, and it was confirmed the rv pace was not capturing.There was no asystole of greater than 2 seconds observed as the patient had a good intrinsic rhythm.It was noted the rv lead looked to be in the same position as when it was implanted a few days ago.Technical services recommended further lead evaluation.Additional information was received that the rv loss of capture was due to high thresholds.The rv lead was not capturing at 7.5 v.The patient experienced stimulation when the rv output was increased, so the decision was made to reposition this rv lead.No additional 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): GUIDANT PUERTO RICO, B.V.; no. 12, road 698; ,; dorado PR 00646 3311
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; ,; saint paul, MN 55112
• MDR Report Key: 8085043
• MDR Text Key: 127587599
• Report Number: 2124215-2018-60941
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/04/2020
• Device Model Number: 0692
• Device Catalogue Number: 0692
• Device Lot Number: 546410
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 50 YR