MAUDE Adverse Event Report: GUIDANT CRM CLONMEL IRELAND ACCOLADE; IMPLANTABLE PULSE GENERATOR

Model Number U128

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

Patient Problems Cardiac Arrest (1762); No Known Impact Or Consequence To Patient (2692)

Event Date 06/28/2017

Event Type  Death  

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 patient presented in cardiac arrest and was successfully resuscitated.Further review showed that this right ventricular (rv) lead had exhibited loss of capture which resulted in asystole for 10 seconds.Boston scientific technical services discussed that a chest x-ray should be performed.At this time, the rv lead remains in service.No additional adverse patient effects were reported.

Manufacturer Narrative

Records indicate this system remained 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

Additional information was received indicating the patient expired approximately one and a half weeks later.There were no allegations against device functionality at the time the patient expired.The local area field representative was contacted for additional information.No further information was available.

• Brand Name: ACCOLADE
• Type of Device: IMPLANTABLE PULSE 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: 6747445
• MDR Text Key: 81179809
• Report Number: 2124215-2017-13305
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: (01)00802526559402(17)20181109
• Combination Product (y/n): N
• PMA/PMN Number: P030005/S113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2017

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: 11/09/2018
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/28/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 07/17/2017
• Supplement Dates FDA Received: 08/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2016
• 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: 4674; 7740; 7741; L111; U128
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 84 YR