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 Problem Inadequate Pain Relief (2388)

Event Date 10/12/2016

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-2316-50, serial #: (b)(4), description: infinion 1x16perc lead kit-50cm.

Event Description

A report was received that the patient was experiencing loss of stimulation.It was noted that the patient¿s lead was having high impedances.The patient will undergo a revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Additional information was received that the patient underwent a revision procedure wherein the leads, splitters, and clik anchors were replaced.Device malfunction was suspected.The patient was doing well postoperatively.

Event Description

A report was received that the patient was experiencing loss of stimulation.It was noted that the patient¿s lead was having high impedances.The patient will undergo a revision procedure wherein the leads will be replaced.

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-3400-30, serial#: (b)(4), description: infinion splitter 2x8 kit (30 cm).Model#: sc-4316, lot#: 19540149, description: next generation anchor kit-sterile sc-2316-50 (sn (b)(4)).Device evaluation indicated that the complaint has been confirmed.Visual (microscope) and x-ray inspection of the leads revealed that all of the cables were completely broken at the bent/kinked location of the lead.The bent/kinked location was 1 cm 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 devices passed all tests performed.Sc-4316 (ln 19540149) device evaluation indicated that the device passed all tests performed.

Event Description

A report was received that the patient was experiencing loss of stimulation.It was noted that the patient¿s lead was having high impedances.The patient will undergo a revision procedure wherein the leads will be replaced.

• 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: 6182493
• MDR Text Key: 62678953
• Report Number: 3006630150-2016-03813
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: (01)08714729797814(17)170318(10)66104
• 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: 12/07/2016

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: 03/18/2017
• Device Model Number: SC-2316-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/17/2017; 03/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2015
• 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
• Patient Age: 69 YR