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); Component Missing (2306)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/08/2016

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

A report was received that the patient was experiencing loss of stimulation.High impedances were noted.The patient underwent a revision procedure wherein the leads were replaced.Device malfunction was suspected.The patient was doing well post-operatively.

Manufacturer Narrative

Sc-1132 (sn (b)(4)): device evaluation indicated that the ipg passed all the required tests and revealed no anomalies.Sc-3400-30 (sn (b)(4)): device evaluation indicated that the leads passed all the required tests and revealed no anomalies.Ssc-4316 (ln 18428206): device evaluation indicated that the clik anchors have damaged eyelet, and the part of silicon material from one of the damaged eyelets was missing.Sc-2316-50 (sn (b)(4)): device evaluation indicated that the lead complaint was confirmed.15 cables were fractured at the kinked sections of the lead body where cliks anchored.No cables are exposed.Sc-2316-50 (sn (b)(4)): device evaluation indicated that the lead complaint was confirmed.The lead was cut, and the proximal tip was not returned.X-ray inspection on the remaining of the lead found several cable fractures at the kinked sections of the lead body where cliks anchored.No cables are exposed fracture location is 1 cm from the clik anchor set screw mark.No cables are exposed.The fractured cables resulted in the reported complaint.

Event Description

A report was received that the patient was experiencing loss of stimulation.High impedances were noted.The patient underwent a revision procedure wherein the leads were replaced.Device malfunction was suspected.The patient was doing well post-operatively.

Manufacturer Narrative

Additional information was received that the missing eyelets were explanted.

Event Description

A report was received that the patient was experiencing loss of stimulation.High impedances were noted.The patient underwent a revision procedure wherein the leads were replaced.Device malfunction was suspected.The patient was doing well post-operatively.

• 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: 6206594
• MDR Text Key: 63363221
• Report Number: 3006630150-2016-03914
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: (01)08714729797814(17)180406(10)19099837
• 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: 12/08/2016

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: 04/06/2018
• Device Model Number: SC-2316-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2016
• Initial Date FDA Received: 12/27/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/22/2017; 04/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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: 53 YR