MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC; LINEAR ST 50 CM LEAD

Model Number SC-2218-50

Device Problems Detachment Of Device Component (1104); Difficult to Insert (1316); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 07/07/2017

Event Type  malfunction  

Event Description

Spinal stimulator lead was difficult to place so withdrawn.Upon inspection of lead tip had torn off.

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: LINEAR ST 50 CM LEAD
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 6771052
• MDR Text Key: 82018365
• Report Number: MW5071391
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2019
• Device Model Number: SC-2218-50
• Device Lot Number: 3168024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 80 YR