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

Model Number	SC-2158-70
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: model#: sc-2158-70 serial#: (b)(4), description: linear lead with enhanced stylet, 70cm; model#: sc-4316 lot#: 16480437 description: next generation anchor kit-sterile.
Event or Problem Description
A report was received that the patient had a fractured lead.The patient will undergo a revision procedure.
Additional Manufacturer Narrative
Additional information was received that the patient will have her current scs system explanted due to a fall and loss of functionality of device.It was believed that the fall was not due to device malfunction.
Event or Problem Description
A report was received that the patient had a fractured lead.The patient will undergo a revision procedure.
Additional Manufacturer Narrative
Additional information was received that the patient underwent a full scs system revision wherein the leads were replaced.The patient was doing well postoperatively.A review of the manufacturing documentation for the leads revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
Event or Problem Description
A report was received that the patient had a fractured lead.The patient will undergo a revision procedure.

• 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: 7505204
• Report Number: 3006630150-2018-01624
• Device Sequence Number: 10808951
• Product Code: LGW
• UDI-Device Identifier: 08714729767718
• UDI-Public: 08714729767718
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2018

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/02/2015
• Device Model Number: SC-2158-70
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/19/2018
• Supplement Date Received by Manufacturer: 06/14/2018; 07/30/2018
• Initial Report FDA Received Date: 05/10/2018
• Supplement Report FDA Received Date: 07/10/2018; 08/14/2018
• 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
• Patient Age: 50 YR