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

Model Number U128

Device Problems High impedance (1291); Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, a thorough evaluation of the device was performed.Visual and mechanical inspection of the rv set screw was performed and no anomalies were noted.The lead barrel was found to be free of obstruction.There was a hole noted in the rv seal plug.The device was then exposed to simulated heart load conditions, and the pacing, and sensing functions were tested.Impedance testing was completed and all measurements were within normal limits.The device operated appropriately with no interruptions in therapy output at the returned programmed settings.A series of electrical tests was also performed, and again, normal device function was observed.Laboratory analysis was unable to reproduce the clinical observations during testing.

Event Description

Boston scientific received information that the patient with this cardiac resynchronization therapy pacemaker (crt-p) was seen for a recent patient follow up and reported that he experienced a fall in (b)(6) 2017.A review of the memory revealed that an episode was recorded where there was oversensing of the respiratory rate trend (rrt) signal.The patient had a slow intrinsic rhythm and pacing inhibition did not last longer than two seconds.The pacing impedance measurements have remained stable, but there was an increase to 800 ohms around the day of the patient's fall.Further testing was performed and both noise was able to be recreated with patient movements as well pacing impedance measurements were above 3,000 ohms.A chest x-ray was performed and no issues were observed with the non-boston scientific right ventricular (rv) lead or with the connection.Boston scientific technical services (ts) was contacted and discussed additional troubleshooting.A revision was performed.The physician performed a tug test on the rv lead and confirmed that it was secured in the header.The terminal pin rv lead was then removed from the port and measurements were taken on the psa; all measurements were in normal range and no noise was observed.The rv lead was reconnected to the crt-p; however, noise was able to be recreated with lead manipulation.The crt-p was explanted and successfully replaced.When the rv lead was connected to the new device, the noise was still present.As a result, the non-boston scientific rv lead was capped and successfully replaced.No additional 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 ; 6515824786
• MDR Report Key: 6522982
• MDR Text Key: 73738213
• Report Number: 2124215-2017-07270
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: (01)00802526559402(17)20180917
• 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
• Report Date: 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/17/2018
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2016
• 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
• Treatment: 4076; 4677; U128
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 77 YR