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

Model Number SC-2316-50

Device Problems Fracture (1260); High impedance (1291); Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/29/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2316-50 serial #: (b)(4), description: infinion 1x16 percutaneous lead kit-50cm model #: sc-3400-30 serial #: (b)(4), description: infinion splitter 2x8 kit (30 cm).

Event Description

A report was received that the patients contacts were showing high impedances.The patient underwent a full scs system replacement procedure.

Manufacturer Narrative

Additional information was received that the physician had explanted and replaced all of the patients old scs system.Sc-1132 (sn: (b)(4)) device evaluation indicated that the ipg passed all tests performed.Sc-2316-50 (sn: (b)(4)) device evaluation indicated that the complaint was confirmed.Visual inspection revealed that the lead body was kinked right after the retention sleeve in the proximal end.All 16 cables were fractured at the damaged section of the lead and it resulted in high impedances.No cables were exposed at the site.Sc-2316-50 (sn: (b)(4)) device evaluation indicated that the complaint was confirmed.14 cables were fractured on the lead body at the kinked section where the clik-anchor was positioned.Fracture location is 1 cm from the clik anchor set screw mark.The fractured cables resulted in high impedances.No cables were exposed.Sc-3400-30 (sn: (b)(4)) device evaluation indicated that the complaint was confirmed.E#14 cable was broken at the weld nugget of the contact spring inside the boot.No cables were exposed at the site.Sc-3400-30 (sn: (b)(4)) device evaluation indicated that the device passed all tests performed.Sc-1318: device evaluation indicated that the eyelets were torn, and silicone material from one of the eyelets was missing.

Event Description

A report was received that the patients contacts were showing high impedances.The patient underwent a full scs system replacement procedure.

Manufacturer Narrative

Correction to mdr fu#1 in field.Should have been; additional information was received that the physician had explanted and replaced all of the patients old scs system.Sc-1132 (sn: (b)(4)) device evaluation indicated that the ipg passed all tests performed.Sc-2316-50 (sn: (b)(4)) device evaluation indicated that the complaint was confirmed.Visual inspection revealed that the lead body was kinked right after the retention sleeve in the proximal end.All 16 cables were fractured at the damaged section of the lead and it resulted in high impedances.No cables were exposed at the site.Sc-2316-50 (sn: (b)(4)) device evaluation indicated that the complaint was confirmed.14 cables were fractured on the lead body at the kinked section where the clik-anchor was positioned.Fracture location is 1 cm from the clik anchor set screw mark.The fractured cables resulted in high impedances.No cables were exposed.Sc-3400-30 (sn: (b)(4)) device evaluation indicated that the complaint was confirmed.E#14 cable was broken at the weld nugget of the contact spring inside the boot.No cables were exposed at the site.Sc-3400-30 (sn: (b)(4)) device evaluation indicated that the device passed all tests performed.Sc-4316: device evaluation indicated that the eyelets were torn, and silicone material from one of the eyelets was missing.

Event Description

A report was received that the patients contacts were showing high impedances.The patient underwent a full scs system replacement procedure.

Manufacturer Narrative

Correction to mdr fu #2 mdr in field - should have been (b)(6) 2018.

Event Description

A report was received that the patients contacts were showing high impedances.The patient underwent a full scs system replacement procedure.

• Brand Name: PRECISION SPECTRA
• 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: 7131598
• MDR Text Key: 95333775
• Report Number: 3006630150-2017-05358
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: 08714729797814
• 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,Followup,Followup,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/14/2015
• Device Model Number: SC-2316-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/21/2013
• 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 Age: 59 YR