MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ACCOLADE; IMPLANTABLE PULSE GENERATOR

Model Number U128

Device Problems Failure to Capture (1081); Pocket Stimulation (1463); Capturing Problem (2891)

Patient Problems Muscle Stimulation (1412); No Known Impact Or Consequence To Patient (2692)

Event Date 09/27/2016

Event Type  Injury  

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

Event Description

Boston scientific received information that due to the markers on the electrogram (egm), there was concern over possible left ventricular (lv) lead loss of capture (loc).It was noted that the output had been decreased at the previous visit due to chest wall stimulation.The other manufacturer's lv lead threshold measurements had increased.The patient was noted to be ventricular dependent, but was pacing in the right ventricle without issue and there were no adverse patient effects.The patient was brought back into the clinic where they repeated lv threshold testing and changed the sensing vector.Two months later the patient contacted the clinic with complaints of feeling "a little bit off." review of the remote home monitoring data found that there was now lv loc in the previously programmed vector.Boston scientific technical services (ts) was consulted and suggested bringing the patient in to test other vectors and possibly increase the output.The clinic opted to have the patient performed another transmission which showed lv capture.The physician has opted to continue to monitor the patient for now and will have the patient come into the clinic when normally scheduled.The patient was asymptomatic.The cardiac resynchronization therapy pacemaker (crt-p) and lv lead remain in service.

• Brand Name: ACCOLADE
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7496206
• MDR Text Key: 107683876
• Report Number: 2124215-2018-08293
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/25/2018

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: 08/14/2017
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2015
• 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): Life Threatening; Required Intervention
• Patient Age: 74 YR