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

Model Number SC-2316-50

Device Problems Bent (1059); Break (1069); Fracture (1260); High impedance (1291); Kinked (1339); Device Or Device Fragments Location Unknown (2590)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/09/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A report was received that the patient was receiving infective therapy.An impedance check revealed that one of the leads displayed high impedances.The patient will undergo a revision wherein the physician plans on replacing the lead and lead splitter.

Event Description

A report was received that the patient was receiving infective therapy.An impedance check revealed that one of the leads displayed high impedances.The patient will undergo a revision wherein the physician plans on replacing the lead and lead splitter.

Manufacturer Narrative

Additional information was received that the patient underwent a replacement procedure wherein the leads, splitters and clik anchors were replaced.The patient was doing well post-operatively.Additional suspect medical device component involved in the event: model #: sc-4316 , lot #: 19526748 description: next generation anchor kit-sterile.

Event Description

A report was received that the patient was receiving infective therapy.An impedance check revealed that one of the leads displayed high impedances.The patient will undergo a revision wherein the physician plans on replacing the lead and lead splitter.

Manufacturer Narrative

Correction to initial mdr report: (b)(6) 2017 sc-2316-50 sn (b)(4): the complaint of high impedance was not confirmed.The returned device was analyzed and no anomalies were found.Sc-2316-50 sn (b)(4): the complaint has been confirmed.Visual (microscope) and x-ray inspection of the lead revealed that all of the cables were completely broken at the bent/kinked location of the lead.The bent/kinked location is 1 cm from the set screw mark of the clik anchor.There are no exposed cables at the fracture locations.The reported complaints of loss of stimulation and high impedances were caused by the fractured cables at the clik anchor site.Sc-3400-30 sn (b)(4): the complaint of high impedance was not confirmed.The returned devices were analyzed and no anomalies were found.Sc-4316 qty 2 visual inspection found that one of the clik anchors has torn eyelets, and a small piece of silicone was not returned.The other clik anchor exhibits normal characteristics.It has been confirmed that all the silicone was removed from the patient.

Event Description

A report was received that the patient was receiving ineffective therapy.An impedance check revealed that one of the leads displayed high impedances.The patient will undergo a revision wherein the physician plans on replacing the lead and lead splitter.

• 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: 6290954
• MDR Text Key: 66194012
• Report Number: 3006630150-2017-00265
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: (01)08714729797814(17)170218(10)17696906
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/09/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/18/2017
• Device Model Number: SC-2316-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2017
• Initial Date FDA Received: 01/31/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; 06/21/2017
• Supplement Dates FDA Received: 02/22/2017; 05/18/2017; 07/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2015
• 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