MAUDE Adverse Event Report: GUIDANT ANGLETON/ST. PAUL IROX; IMPLANTABLE LEAD

Model Number 431-07

Device Problems Over-Sensing (1438); Pacing Problem (1439); Ambient Noise Problem (2877)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

The lead was surgically abandoned and is not expected to be returned.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 pacemaker and right ventricular (rv) lead exhibited noise, oversensing and an unknown duration of pacing inhibition.The patient was noted to not be pacemaker dependent, however, a lead revision procedure was planned.Additional information was received that an invasive procedure was performed.The lead was surgically abandoned and replaced and the pacemaker remains implanted and in service.The root cause of the reported observations was not determined.No additional adverse patient effects were reported.

• Brand Name: IROX
• Type of Device: IMPLANTABLE LEAD
• Manufacturer (Section D): GUIDANT ANGLETON/ST. PAUL; intermedics; angleton TX
• Manufacturer (Section G): GUIDANT ANGLETON/ST. PAUL; intermedics; angleton TX
• Manufacturer Contact: sonali vasekar ; 4100 hamline ave. n; st. paul, MN ; 6515824786
• MDR Report Key: 6052500
• MDR Text Key: 58243846
• Report Number: 2124215-2016-13206
• Device Sequence Number: 1
• Product Code: DTD
• 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: Physician
• Type of Report: Initial
• Report Date: 07/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 431-07
• Other Device ID Number: IROX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 1194; 292-05; 431-07; 7742; K172
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 79 YR