MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV ACCOLADE; IMPLANTABLE PULSE GENERATOR

Model Number ACCESSORY

Device Problem Human-Device Interface Problem (2949)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/18/2016

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 this patient with an cardiac resynchronization therapy pacemaker (crt-p) device had perforation and tamponade during implant.Moreover, the patient had history of atrial fibrillation (af).The device remains in service.No additional adverse patient effects were reported.

Event Description

Boston scientific received information that during implant procedure for this cardiac resynchronization therapy pacemaker (crt-p) device, when canulating the coronary sinus to implant another manufacturer's left ventricular (lv) lead, a perforation and tamponade occurred.Additional information was received that there was a pericardial effusion and the pericardium was successfully drained during the procedure.At this time there is no evidence to support that the crt-p contributed to the perforation and both the crt-p and another manufacturer's lv lead remain in service.No additional adverse patient effects were reported.

• Brand Name: ACCOLADE
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT PUERTO RICO BV; guidant ireland; clonmel, tipperary ireland
• Manufacturer (Section G): GUIDANT PUERTO RICO BV; guidant ireland; clonmel, tipperary ireland
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 5632506
• MDR Text Key: 44447158
• Report Number: 2124215-2016-06599
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/06/2018
• Device Model Number: ACCESSORY
• 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
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2016
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 71 YR