MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR

Model Number	SC-2366-30
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/13/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that following an explant procedure, the device analysis revealed the lead was fractured at the distal electrode array.There were no abnormalities detected on the lead prior to the explant procedure.It is unknown what caused the fracture.
Event or Problem Description
A report was received that following an explant procedure, the device analysis revealed the lead was fractured at the distal electrode array.There were no abnormalities detected on the lead prior to the explant procedure.It is unknown what caused the fracture.

• Brand Name: PRECISION
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 6176669
• Report Number: 3006630150-2016-03748
• Device Sequence Number: 890966
• Product Code: LGW
• UDI-Device Identifier: 08714729789659
• UDI-Public: (01)08714729789659(17)140418(10)15160524
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 04/18/2014
• Device Model Number: SC-2366-30
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/13/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention