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

Model Number SC-2316-50

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 03/16/2016

Event Type  Injury  

Event Description

A report was received that the patient was experiencing increased pain and poor capture of painful area as the spinal cord stimulator (scs) leads were nonfunctioning.High impedances were noted and the patient will undergo a revision procedure.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the leads and click anchor were replaced due to suspected malfunction.The patient was doing well postoperatively.Additional suspect medical device components involved in the event: model #: sc-2316-50, serial #: (b)(4), description: infinion 1x16 perc lead kit-50 cm; model #: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit (30 cm); model #: sc-4316, lot #: 17294047 description: next generation anchor kit sterile.

Event Description

A report was received that the patient was experiencing increased pain and poor capture of painful area as the spinal cord stimulator (scs) leads were nonfunctioning.High impedances were noted and the patient will undergo a revision procedure.

Manufacturer Narrative

Sc-2316-50 (sn (b)(4)) device evaluation indicated that the complaint was 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 was 1cm from the set screw mark of the clik anchor.There were no exposed cables at the fracture locations.Sc-3400-30 (sn (b)(4)) device evaluation indicated that the splitters passed all test performed.Sc-4316 (ln 17294047) device evaluation indicated that the clik anchors passed all test performed.

Event Description

A report was received that the patient was experiencing increased pain and poor capture of painful area as the spinal cord stimulator (scs) leads were nonfunctioning.High impedances were noted and the patient will undergo a revision 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: 6440294
• MDR Text Key: 71069950
• Report Number: 3006630150-2017-01061
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: (01)08714729797814(17)161013(10)17354108
• 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
• Report Date: 03/10/2017

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/13/2016
• Device Model Number: SC-2316-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 03/28/2017
• Supplement Dates Manufacturer Received: 06/20/2017; 08/10/2017
• Supplement Dates FDA Received: 07/12/2017; 08/30/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2014
• 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
• Patient Age: 73 YR