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

Model Number 430-10-52

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2016

Event Type  Injury  

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 Description

Boston scientific received information that this right ventricular (rv) lead had insulation damaged.Additional information received from the field representative indicates that lead was fractured and the physician assumed that it was clavicular crush.This rv lead was removed and returned back to the laboratory.No additional adverse patient effects were reported.

• Brand Name: THINLINE
• 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: 6056561
• MDR Text Key: 58356338
• Report Number: 2124215-2016-12662
• Device Sequence Number: 1
• Product Code: NVZ
• 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: 07/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/01/2000
• Device Model Number: 430-10-52
• Other Device ID Number: ---
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/13/2016
• 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: 1273; 1294; 4136; 430-10-52; 438-10-45; K173
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 78 YR