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

Model Number SC-1110

Device Problems Bent (1059); Fracture (1260); Kinked (1339)

Patient Problem No Information (3190)

Event Date 03/09/2016

Event Type  Injury  

Manufacturer Narrative

Other # field is populated with the di number.Additional suspect medical device components involved in the event: model #: sc-2138-50, serial #: (b)(4), description: scs 50cm iii, lead sc-1110, sn (b)(4): device evaluation indicated that the ipg passed all tests performed.The ipg exhibited normal device characteristics.Sc-2138-50, sn (b)(4).Device evaluation indicated that the lead passed all tests performed.The device exhibited normal device characteristics.Sc-2138-50, sn (b)(4).Device evaluation indicated that the visual (microscope) and x-ray inspection of the lead revealed that multiple of the cables were completely broken at the bent/kinked location of the lead.This location appeared to be the site where the suture was positioned.No cables were exposed at the fracture site.

Event Description

A report was received that the patient underwent an explant procedure for an unknown reason.

• Brand Name: PRECISION®
• Type of Device: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 5547658
• MDR Text Key: 41884463
• Report Number: 3006630150-2016-00804
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2016

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?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/30/2008
• Device Model Number: SC-1110
• Other Device ID Number: M365SC11100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2016
• Initial Date FDA Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2007
• 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
• Patient Outcome(s): Required Intervention