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

Model Number V173

Device Problems Over-Sensing (1438); Pacing Problem (1439); Device Displays Incorrect Message (2591)

Patient Problems Syncope (1610); Edema (1820)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

Analysis of the returned product is currently ongoing.This report will be updated upon completion of the analysis.

Event Description

Boston scientific received information that the patient with this pacemaker experienced a syncopal episode.The patient presented to the hospital and there were four to five second pauses in pacing noted on the telemetry monitor.Upon device interrogation the device was in safety mode.There was also a fault code indicating a potential memory issue.It was reported that this patient was pacemaker dependent and the default parameters for unipolar pacing in safety mode were not sufficient, as the programmed sensitivity allowed oversensing for six to nine seconds.There was no known exposure to an magnetic resonance imaging (mri) or radiation therapy.No additional adverse patient effects were reported.

Manufacturer Narrative

Upon receipt at our post market quality assurance laboratory, this device was thoroughly inspected and analyzed.Interrogation of the device confirmed it was operating in safety core and that both brady and tachy therapy remained available.Review of device memory identified a fault.The fault resulted in software resets performed in an attempt to correct an identified memory inconsistency.The corrupted memory was corrected in the laboratory and the device reverted to normal operation.The cause of the memory inconsistency was not able to be determined through laboratory testing.

Manufacturer Narrative

Additional information received from the local field representative indicated that they were not contacted regarding the reported issue.It is likely that the physician/hospital managed the reported issue as it was not specific to device functionality.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 received from the patient indicated that there were complications as a result of the replacement procedure.The patient was in the hospital for four days following the replacement and then was sent to a rehabilitation facility for ten days.The patient reported experiencing a build up of fluid in their chest.The patient reported they were hospitalized a second time as a result of this procedure.

• Brand Name: INGENIO
• 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 ; 6515824786
• MDR Report Key: 6504218
• MDR Text Key: 73193616
• Report Number: 2124215-2017-06308
• Device Sequence Number: 1
• Product Code: NKE
• 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,Followup,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/11/2014
• Device Model Number: V173
• Other Device ID Number: INVIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2012
• 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
• Treatment: 4135; 4136; MISMATCH; U125; V173
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 95 YR