MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND INCEPTA; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number P163

Device Problems Over-Sensing (1438); Pacing Problem (1439); Pocket Stimulation (1463); Ambient Noise Problem (2877)

Patient Problem Muscle Stimulation (1412)

Event Date 04/07/2016

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 during a routine follow up noise was observed when it comes to this device.Ventricular tachycardia (vt) and ventricular fibrillation (vf) markers were noted with reported pacing inhibition for three to four seconds.The patient was pacemaker dependent.Provocation maneuvers were performed and small amplitude noise signals were seen, likely due to muscle stimulation.A memory dump was performed.The patient was hospitalized for a possible system revision in order to assess the system.The lead implanted is a competitor lead.No adverse patient effects were reported.Additional information noted that a revision procedure took place next day and it was noted that the competitor lead showed insulation damage.Another competitor lead was used and tested well with a pacing system analyzer (psa) and connected to the right ventricular port.No additional adverse patient effects were reported.

• Brand Name: INCEPTA
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• 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: 5787176
• MDR Text Key: 49360707
• Report Number: 2124215-2016-07172
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): N
• 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: 04/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/25/2016
• Device Model Number: P163
• Other Device ID Number: INCEPTA CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/07/2016
• Initial Date FDA Received: 07/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2014
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention