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

Model Number U128

Device Problems High impedance (1291); Over-Sensing (1438); Pocket Stimulation (1463); Ambient Noise Problem (2877)

Patient Problem Muscle Stimulation (1412)

Event Date 09/15/2017

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

Boston scientific received information that a lead safety switch (lss) was declared for a high out of range pacing impedance of greater than 2000 ohms in the left ventricle (lv) and right ventricle (rv).Technical services reviewed device data and determined the impedances in both the lv and rv were trending the same.The representative was unable to recreate any measurement issues with isometrics.Additional troubleshooting options were discussed.The decision was made to program the lv lss off because the patient felt stimulation, but to leave the associated rv lss on so the patient has unipolar sensing in the rv if needed.Additional information was received that the root cause for the event remains unknown.The lv lead configuration was reprogrammed.At this time, this cardiac resynchronization therapy pacemaker (crt-p) remains in service and the patient will continue to be monitored.There were no adverse patient effects reported.

Event Description

Additional information was received that another lead safety switch (lss) was declared for a high out of range right ventricular (rv) pacing impedance of greater than 2000 ohms.The impedance was noted to be greater than 3000 ohms.Technical services reviewed the device data, and noted there were also 48 ventricular sensed events after the lss occurred.Discussed this may have been due to myopotential noise after the rv lead switched to a unipolar configuration.Technical services discussed additional troubleshooting options.At this time, no further troubleshooting will be performed and the patient will continue to be monitored.This cardiac resynchronization therapy pacemaker (crt-p) remains in service and there were no adverse patient effects 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: 6938774
• MDR Text Key: 90064215
• Report Number: 2124215-2017-18703
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030005/S113
• 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: 12/19/2017

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: 05/27/2018
• 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: 09/30/2017
• Initial Date FDA Received: 10/10/2017
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2016
• 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: 78 YR