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

Model Number N141

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Respiratory Failure (2484)

Event Date 02/17/2015

Event Type  Death  

Event Description

Further information as then received that this patient was never discharged from the hospital and subsequently died.According to the physician, the procedure may have caused or contributed to the patient's death.The field representative was unaware of the official cause of death.No post-mortem device evaluation was performed nor was the device explanted.

Manufacturer Narrative

(b)(4).

Event Description

Boston scientific received information from the patient's family that this patient died when the generator was replaced.Further review of the records, shows that the patient died approximately five days after the generator replacement, and according to the on-line obituary the death occurred in the hospital.Further information has been requested from the field.Additional information was received from the local field representative.At the time of the generator change-out the patient had complications attributed to anesthesia and went into respiratory arrest.A code was called.There were no device related issues, but the lower pacing rate limit was increased to provide additional support at the time.The patient was transferred in unstable condition to the intensive care unit.The field representative was never contacted for any additional device evaluations.

Manufacturer Narrative

(b)(4).As no further information concerning this report is currently available, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: ENERGEN
• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN 55112 ; 6515824786
• MDR Report Key: 4725082
• MDR Text Key: 5746626
• Report Number: 2124215-2015-05496
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2015

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/21/2016
• Device Model Number: N141
• Other Device ID Number: ENERGEN CRT-D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/27/2015
• Initial Date FDA Received: 04/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2014
• 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: 6947; N141; 5076; C154DWK; 4194
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 80 YR