MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION CORPORATION FIXATE ; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	FB-201-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/21/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Device disengaged prematurely preventing anchorage of spinal cord stimulator lead.Another fixate device had to be opened to anchor lead.No mention of product malfunction in procedural note.No patient harm; no affect on outcomes.

• Brand Name: FIXATE
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 4100 hamline ave n; saint paul MN 55112
• MDR Report Key: 7937885
• Report Number: 7937885
• Device Sequence Number: 2269572
• Product Code: GAT
• UDI-Device Identifier: 08714729836834
• UDI-Public: (01)08714729836834(17)210715(10)20877230
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2018
• Report Date (Section F): 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FB-201-01
• Device Lot Number: 20877230
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/27/2018