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

Model Number	K272
Medical Device Problem Codes	Failure to Capture (1081); Pacing Problem (1439); Ambient Noise Problem (2877)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Dizziness (2194)
Date of Event	03/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was retained by the hospital pathology department.At this time, the product has not been returned.If the product is returned, analysis will be performed and this report would be updated at that time.
Event or Problem Description
Boston scientific received information that this pacemaker exhibited noise and pacing inhibition.There was asystole greater than 2 seconds.It was suspected that there was a lead fracture on the right atrial (ra) competitor lead.A procedure was performed to explant the lead at which time a lead fracture was confirmed on the lead near the pocket.During the procedure, there was pacing inhibition while the device was in cautery mode.Boston scientific technical services (ts) discussed that the pacing inhibition was likely due to the exposed fracture being near the cautery.The fractured lead was surgically abandoned.The device was also explanted and replaced with an upgraded device.No adverse patient effects were reported.

• Brand Name: INGENIO
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• MDR Report Key: 5601741
• Report Number: 2124215-2016-05083
• Device Sequence Number: 10840111
• Product Code: LWP
• UDI-Device Identifier: 00802526516955
• UDI-Public: (01)00802526516955(17)20150722
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N970003/S143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 03/02/2016

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/22/2015
• Device Model Number: K272
• Other Device ID Number: VITALIO
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2016
• Initial Report FDA Received Date: 04/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 63 YR