MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EASYTRAK 3 IS-1; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 4549

Device Problems High impedance (1291); Failure to Select Signal (1582)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/19/2019

Event Type  malfunction  

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

It was reported that this patient's device had been emitting tones which were not reported immediately.System evaluation identified an alert for out of range pacing impedance measurements and intrinsic amplitude measurements on the left ventricular (lv) channel.Pacing impedance measurements had exceeded 2000 ohms.No patient symptoms were reported.A boston scientific technical services consultant documented and discussed the clinical observations with the caller.No adverse patient effects were reported.

• Brand Name: EASYTRAK 3 IS-1
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (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 ; 6515826168
• MDR Report Key: 9104894
• MDR Text Key: 159692745
• Report Number: 2124215-2019-17483
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00802526420399
• UDI-Public: 00802526420399
• Combination Product (y/n): N
• PMA/PMN Number: P010012/S032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/23/2009
• Device Model Number: 4549
• Device Catalogue Number: 4549
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/23/2007
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR