MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND AUTOGEN; IMPLANTABLE CHF GENERATOR

Model Number G179

Device Problems Pacing Problem (1439); Ambient Noise Problem (2877); Capturing Problem (2891); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/24/2015

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 during routine post-implant hospitalization an external electrocardiogram was collected showing an episode of pacing inhibition and asystole believed to occur at the time of an automatic right ventricular (rv) lead threshold test.Boston scientific technical services (ts) noted two pacing spikes and suggested it may have correlated to sequential a-v pacing during an automatic threshold test.A ventricular fibrillation (vf) episode was also stored to the device but appeared to be consistent with noise due to air bubble entrapment in the device header.Despite the reported asystole the patient did not experience any adverse effects or symptoms.Fluoroscopy was performed which ruled out lead dislodgement though ts noted the rv lead may not be placed in an optimal position.Information was later received indicating the physician believed the lead position to be adequate and stable despite placement difficulty at implant requiring the lead to be repositioned.Ts reviewed additional device data and noted ambulatory rv auto threshold testing did not appear enabled for the cardiac resynchronization therapy defibrillator (crt-d) as multiple fixed output values were programmed within a relatively short period.A subsequent follow up was performed during which time sensing, impedance and threshold measurements of all three leads were observed stable and equal to those observed at implant.Provocative maneuvers were also performed and noise could not be reproduced.Ts suggested that if everything appeared stable and the commanded auto threshold test provided lower thresholds that continued monitoring of the patient may be appropriate.The left ventricular (lv) pacing vector was reprogrammed.No adverse patient effects were reported.This system remains in service.

• Brand Name: AUTOGEN
• Type of Device: IMPLANTABLE CHF 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5373207
• MDR Text Key: 36525595
• Report Number: 2124215-2015-16521
• Device Sequence Number: 1
• Product Code: OSR
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: N/A
• 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: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 12/01/2016
• Device Model Number: G179
• Other Device ID Number: AUTOGEN X4 CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A¿INTERNATIONAL ONLY
• Patient Sequence Number: 1
• Patient Age: 91 YR