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

Model Number U128

Device Problems Failure to Capture (1081); Ambient Noise Problem (2877); Capturing Problem (2891); Impedance Problem (2950)

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

Event Date 03/28/2018

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 this cardiac resynchronization therapy pacemaker (crt-p) system displayed right atrial (ra) loss of capture.The atrial output was set to auto 2.0 v.The manual threshold test that was run in the office was 2.4 v.The ra impedance trend is fluctuating between 400 ohms and 1000 ohms.Technical services reviewed device data, and noted the most recent threshold test displayed a good threshold of 0.7 v.Technical services discussed how the device assesses capture.Technical services had the caller retest in unipolar, and the ra threshold was 0.6 v and the impedance was 260 ohms.The decision was made to reprogram the ra lead to unipolar and the patient will be monitored.It was noted there was noise on the right ventricular (rv) lead in the past, so that lead is programmed unipolar pace and bipolar sense.At this time, this crt-p and competitor ra and rv leads remain 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: 7618290
• MDR Text Key: 111640285
• Report Number: 2124215-2018-08357
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: 00802526559402
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/22/2018
• 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
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/22/2016
• 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: 1291; 1297; 1388T; 253-05; 283-03; 293-09; 294-05; 430-07; 433-02; 467-01; 4674; MISMATCH; PR48B; S606; U128
• Patient Age: 71 YR