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

Model Number U128

Device Problems High impedance (1291); Over-Sensing (1438); Ambient Noise Problem (2877)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Boston scientific received information that this cardiac resynchronization therapy pacemaker (crt-p) system declared a lead safety switch for a high out of range right atrial (ra) pacing impedance of greater than 3000 ohms.Technical services reviewed the ra lead impedance trend values over the last year and noted the ra impedance varied from around 500 ohms to greater than 3000 ohms when programmed in a bipolar configuration.When the ra lead was in a unipolar configuration, the pacing impedances were very stable in the 400 ohms range.Technical services reviewed the logbook and noted there were numerous atrial tachy response (atr) episodes post-lead safety switch when the ra lead was programmed unipolar.The atr episodes were due to oversensing of myopotential noise.It was noted there was no noise present when the ra lead was programmed bipolar.There was no minute ventilation oversensing noted.Technical services, however; did recommend programming respiration related trends off, since the ra impedance is high.Technical services discussed possible causes for the clinical observations and provided troubleshooting options.At this time, this crt-p remains in service and there were no adverse patient effects reported.

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

Additional information was received that no further troubleshooting was performed after the initial interrogation.The right atrial (ra) lead was programmed back to bipolar pace/sense and respiration related trends was programmed off.The patient will continue to be monitored.No adverse patient effects were reported.

• 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: 7440007
• MDR Text Key: 105887876
• Report Number: 2124215-2018-07115
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2019
• 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
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2017
• 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 Age: 65 YR