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

Model Number	S403
Medical Device Problem Codes	Over-Sensing (1438); Pacing Problem (1439); Failure to Sense (1559); Low impedance (2285); Ambient Noise Problem (2877); Capturing Problem (2891)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 there were three or more episodes of asystole due to oversensing of noise on the right ventricular (rv) channel.The rv lead also exhibited increased threshold measurements and non detection of sensing.Aggressive manipulation of pocket was unable to reproduce any noise or oversensing.Outputs and sensitivity were reprogrammed and the patient was hospitalized for a revision procedure.The pacemaker was interrogated the following day with programming showing the device to be pacing and sensing in the ventricle only, however pauses in pacing were still observed thus a temporary pacing wire was placed.It was also noted that the rv impedance measurements were at 400 ohms currently but was 1190 at implant.A revision procedure was performed where the rv lead was surgically abandoned and the pacemaker was explanted.A new device and lead were successfully implanted and no additional adverse patient effects were reported.

• Brand Name: ALTRUA
• Common Device Name: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): GUIDANT CRM CLONMEL IRELAND; guidant ireland; clonmel, tipperary ireland
• MDR Report Key: 7407906
• Report Number: 2124215-2018-05024
• Device Sequence Number: 16456750
• Product Code: LWP
• UDI-Device Identifier: 00802526484445
• UDI-Public: 00802526484445
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 01/30/2018

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: 02/28/2013
• Device Model Number: S403
• Other Device ID Number: ALTRUA 40
• 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: 01/30/2018
• Initial Report FDA Received Date: 04/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 4086; 4087; S403
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 61 YR