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

Model Number 493-05

Device Problems Failure to Capture (1081); Low impedance (2285)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/26/2014

Event Type  Injury  

Event Description

Boston scientific received information that this lead displayed a ventricular lead warning due to low pacing impedances.A review of the data noted that this lead had high pacing thresholds as well.The filed representative wanted to know if there were any advisories when it came to this right ventricular lead before explanting the lead.Technical services noted no advisories were present when it comes to this lead.A device procedure will been scheduled and it was noted that at that time this right ventricular lead will be surgically abandoned.No adverse patient effects were reported.

Event Description

Additional information received noted that the device change-out procedure took place and this right ventricular lead was surgically abandoned.

Manufacturer Narrative

Upon additional information, this investigation will be updated.

• Brand Name: BIOPORE
• 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 55112 ; 6515824786
• MDR Report Key: 3939385
• MDR Text Key: 4532598
• Report Number: 2124215-2014-13937
• Device Sequence Number: 1
• Product Code: DTD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 493-05
• Other Device ID Number: BIOPORE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/03/2014
• 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: 493-05; (B)(4); 253-19
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 82 YR