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

Model Number G124

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574); Ambient Noise Problem (2877)

Patient Problem Complete Heart Block (2627)

Event Date 06/28/2018

Event Type  malfunction  

Manufacturer Narrative

The caller stated the patient will be monitored overnight and re-evaluated the following day.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 following the procedure to implant this device, the patient received a shock when getting off the table.A boston scientific technical services consultant reviewed the device data and discussed with the caller the possibility of air bubbles in the device header.Fluoroscopy confirmed a good lead to device connection.No adverse patient effects were reported.

• Brand Name: MOMENTUM
• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 7978065
• MDR Text Key: 124115118
• Report Number: 2124215-2018-13023
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589102
• UDI-Public: (01)00802526589102(17)20190919
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/17/2018

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: 09/19/2019
• Device Model Number: G124
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2017
• 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: 0293; 4457; 4470; 4542; G124; V173
• Patient Age: 76 YR