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

Model Number U128

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2016

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 the right ventricular (rv) and right atrial (ra) leads were believed to be inadvertently reversed in the header of the cardiac resynchronization therapy pacemaker (crt-p) during the patient's upgrade procedure.Electrogram (egm) strips were sent into boston scientific technical services (ts) for review.Upon review ts did agree that it appeared the leads were reversed in header since the signal on the ra egm comes after the signal on the rv egm and the lvs marker showed the signal on the ra egm is from the rv.Ta revision procedure was performed where lead reversal was confirmed.During the revision the physician opted to surgically abandon the rv lead due to undersensing.The ra lead was left in service and placed in the correct port and a new rv lead was implanted in the correct port in the device.The crt-p remains in service and no additional adverse patient effects were reported.

• 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: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5600073
• MDR Text Key: 43440078
• Report Number: 2124215-2016-03264
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 00802526559402
• UDI-Public: (01)00802526559402(17)20161110
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 02/09/2016

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: 11/10/2016
• Device Model Number: U128
• Other Device ID Number: VALITUDE X4
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/25/2014
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 83 YR