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

Model Number G150

Device Problems Failure to Capture (1081); Pacing Problem (1439); Capturing Problem (2891)

Patient Problems Congestive Heart Failure (1783); Fatigue (1849)

Event Date 11/10/2016

Event Type  Injury  

Manufacturer Narrative

The local area sales representative was contacted for additional information.At this time, no further information is available.Should additional information become available this report will be updated.

Event Description

Boston scientific received information that this cardiac resynchronization therapy defibrillator (crt-d) and right ventricular (rv) lead exhibited high threshold measurements four months post implant.X-rays and fluoroscopic imaging were reviewed and noted no lead dislodgement.A revision procedure was performed and the lead was successfully repositioned and satisfactory threshold measurements were obtained.The root cause was unable to be determined.Subsequently, high thresholds and loss of capture (loc) were later observed.The root cause was still unable to be determined.The patient experienced worsening heart failure symptoms of shortness of breath (sob) and fatigue due to the lack of biventricular pacing.An additional procedure was attempted to explant the lead, however, access was unable to be gained due to scar tissue, so the procedure was abandoned.The patient will be referred for lead explant on an unknown date in the future.No additional adverse patient effects were reported.This product remains implanted and in service.

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

Additional information was received that the rv lead was observed to have dislodged.An invasive procedure was performed.The lead was explanted and replaced.This crt-d remains implanted and in service.No additional adverse patient effects were reported.

• Brand Name: DYNAGEN
• 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: tim degroot ; 4100 hamline ave. n; st. paul, MN ; 6515826168
• MDR Report Key: 6677768
• MDR Text Key: 78717457
• Report Number: 2124215-2017-11343
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 00802526534614
• UDI-Public: (01)00802526534614(17)20180331
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010012/S341
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Model Number: G150
• Other Device ID Number: DYNAGEN 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: 06/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2016
• 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; 4076; 4194; 6931; G150; MISMATCH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR