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

Model Number F102

Device Problems High impedance (1291); Failure to Convert Rhythm (1540)

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

Event Date 05/03/2017

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 this device and right ventricular (rv) lead had a gradual increase in the shock impedance measurements.It was indicated that no shocks were delivered since implant.The physician indicated that the patient received shocks with the previous device.Boston scientific technical services (ts) discussed that the gradual rise in impedance measurements could be a result of ionization.Some testing was performed with revealed shock impedance measurements of 124 ohms prior to testing and 131 ohms after the pacing protocol was performed.Technical services reviewed the available information and indicated the measurements were likely a result of calcification.The physician elected to continue to monitor the system appropriately.No adverse patient effects were reported.

Event Description

Subsequent information was received that there was an ineffective anti-tachycardia pacing (atp) delivered that was stored.No adverse patient effects were reported.

• Brand Name: TELIGEN
• 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: 6703969
• MDR Text Key: 79731389
• Report Number: 2124215-2017-09784
• Device Sequence Number: 1
• Product Code: MVK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/05/2013
• Device Model Number: F102
• Other Device ID Number: TELIGEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2012
• 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): Required Intervention