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); Impedance Problem (2950)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  Injury  

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 both the right ventricular (rv) lead and left ventricular (lv) lead. The pacing impedance for both leads was greater than 2000 ohms. The impedances then went back to a normal range. It was noted there was a lot of noise present after the lss triggered. The noise could be reproduced with isometrics. The noise was oversensed, which resulted in asystole of greater than two seconds. The physician planned to program the device back to a bipolar configuration because the patient is pacer dependent. No further actions were taken. The root cause for the clinical observations was not determined. Additional information was received that further review of the patient¿s data found noise episodes from four months earlier. The noise presented on the right atrial (ra) and rv channels and was oversensed. Boston scientific technical services (ts) reviewed the electrograms (egms) and stated the noise was from the cardiac resynchronization therapy pacemaker (crt-p) oversensing the minute ventilation signal. Ts discussed how to program the rate response trend and minute ventilation features off. It was also noted that another manufacturer¿s ra lead impedance measurement was out of range two years earlier. However, currently the ra lead impedance measurements were within range. The patient was scheduled to have the minute ventilation feature programmed off. The crt-p and all leads 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: 7353644
• MDR Text Key: 102936378
• Report Number: 2124215-2018-03931
• Device Sequence Number: 1
• Product Code: NKE
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 05/18/2017
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 03/20/2018 Patient Sequence Number: 1

Treatment

5076; MISMATCH; U128