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

Model Number U125

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

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

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Boston scientific received information that the cardiac resynchronization therapy pacemaker (crt-p) and right atrial (ra) lead exhibited oversensing of noise leading to inappropriate atrial tachy response (atr).The noise was determined to be due to oversensing of the minute ventilation signal.A lead safety switch (lss) for another manufacturer's ra lead due to high out of range pacing impedance measurements was observed from the previous day.Review of the crt-p's data found occasional spikes in impedance since implant.Boston scientific technical services (ts) suggested turning of the rate response trend.The crt-p and ra lead remain in service and no adverse patient effects were reported.

Manufacturer Narrative

Event Description

Additional information was received that the minute ventilation and rate respond trend features were programmed off in the crt-p.The cause of the high impedance remained unknown.The crt-p and ra lead remain in service and 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: 7196493
• MDR Text Key: 97495734
• Report Number: 2124215-2017-23756
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: 00802526559389
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/23/2018
• Device Model Number: U125
• Other Device ID Number: VALITUDE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2016
• 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: 62 YR