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

Model Number U128

Device Problems High impedance (1291); Ambient Noise Problem (2877)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2017

Event Type  malfunction  

Manufacturer Narrative

The device and lead remain in service.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 this pacemaker and associated right ventricular (rv) lead triggered the lead safety switch (lss) for high, out-of-range pacing impedance measurements.The patient was brought in to evaluate the lead.In the office, in unipolar the impedance was 346 ohms.In bipolar the impedance was 495 ohms with acceptable r-wave measurements.Isometrics and other movements were performed while testing the impedance and all measurements were within normal range.No noise was created with the isometrics.The lead was programmed back to bipolar and was monitored via enrollment in the remote monitoring system.Two weeks later, an alert for an impedance greater than 2,000 ohms was observed.A review of lead measurements in the remote monitoring system found the impedances ranged between 500-1300 ohms, with occasional impedance values that were greater than 2,000 ohms.The clinician planned to leave the lead programmed to unipolar.No adverse patient effects were reported.

Manufacturer Narrative

The device and lead remain in service with no intervention reported.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 additional information.Another lead safety switch (lss) had occurred the following month, indicating the lead was not left programmed to unipolar as previously reported.This was observed at the patient's routine device check in (b)(6) 2018.It was noted the lead measurements were within normal range in both unipolar and bipolar configurations; there was an episode showing noise that was due to the unipolar sensing, but the noise did not inhibit pacing.Technical services again discussed trying to reproduce noise with isometrics and pocket manipulation and doing commanded rv lead impedances if noise was produced.An x-ray was also recommended.The patient did not recall using a tens unit or any item that would cause external noise and impact the impedance measurements.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: 6700385
• MDR Text Key: 79645804
• Report Number: 2124215-2017-09021
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: (01)00802526559402(17)20161111
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• 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: 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/11/2016
• 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: 02/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2015
• 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: 4135; 4136; MISMATCH; U128
• Patient Age: 87 YR