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

Model Number U125

Device Problems Failure to Capture (1081); Low impedance (2285); Ambient Noise Problem (2877); Capturing Problem (2891)

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

Event Date 11/01/2017

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 left ventricular (lv) threshold was 4v, so the health care provider reprogrammed this cardiac resynchronization therapy pacemaker (crt-p) to a different vector to reduce thresholds.However, this resulted in low pacing impedances.There was then a lead safety switch (lss) due to pacing impedance less than 200 ohms, which resulted in an automatic change in lead configuration.The health care provider reported that the non-boston scientific lv lead was not capturing after the lss.The patient was brought into the clinic for evaluation.During evaluation, it was noted that lv pacing impedance had been occasionally out of range for the last several months.There was also noise observed on both the left and right ventricular channels.No adverse patient effects were reported.The crt-p and non-bsc lv lead remain in service.No interventions 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: 7977288
• MDR Text Key: 124092508
• Report Number: 2124215-2018-15751
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559389
• UDI-Public: (01)00802526559389(17)20190126
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/26/2019
• Device Model Number: U125
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/05/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2017
• 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: 4456; ADSR01; MISMATCH; U125
• Patient Age: 89 YR