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

Model Number G138

Device Problems Ambient Noise Problem (2877); Device Operates Differently Than Expected (2913)

Patient Problem Twiddlers Syndrome (2114)

Event Date 05/24/2018

Event Type  Injury  

Manufacturer Narrative

At this time, the device remains implanted.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 this patient experienced twiddlers syndrome.As result, the implanted leads dislodged and migrated into the surgical pocket leading to noisy signals and left ventricular (lv) lead high pacing thresholds.A revision was performed wherein the leads were extracted and this cardiac resynchronization therapy defibrillator (crt-d) was repositioned.The day after the procedure, the crt-d battery consumption elevated.Boston scientific technical services (ts) discussed the calculated consumption was likely affected by the high pacing thresholds and the telemetry maintained for several hours during the reposition.However, values are expected to recover over time.The crt-d remains in service.No additional 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: 7619986
• MDR Text Key: 111691715
• Report Number: 2124215-2018-10809
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526589188
• UDI-Public: 00802526589188
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/24/2018

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: 11/24/2019
• Device Model Number: G138
• Other Device ID Number: MOMENTUM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/24/2018
• Initial Date FDA Received: 06/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/24/2017
• 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: 0180; 4671; 4674; 7740; G138
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR