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

Model Number SC-2218-70

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Defective Device (2588)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/21/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-2316-50 serial #: (b)(4) description: infinion 1x16 perc lead kit-50 cm.

Event Description

A report was received that the patients stimulator had a defective lead and was not working.It was also noted that the patient had high impedance and was experiencing inadequate stimulation.The patient underwent a lead replacement procedure wherein one lead appeared to be fractured right beyond the anchor.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-2218-70 (sn:(b)(4)) device evaluation indicated that visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location was 22 cm from the distal end.X-ray inspection confirmed all cables were fractured.There were no exposed cables at the clik site fracture.The fractured cables resulted in the reported high impedances.Sc-4316 (ln:16445128) device evaluation indicated that the clik anchor revealed no anomalies.

Event Description

A report was received that the patients stimulator had a defective lead and was not working.It was also noted that the patient had high impedance and was experiencing inadequate stimulation.The patient underwent a lead replacement procedure wherein one lead appeared to be fractured right beyond the anchor.The patient was doing well postoperatively.

• 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: 6946034
• MDR Text Key: 89608819
• Report Number: 3006630150-2017-03991
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767749
• UDI-Public: 08714729767749
• 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
• Report Date: 12/01/2017

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: 10/02/2016
• Device Model Number: SC-2218-70
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2017
• Initial Date FDA Received: 10/12/2017
• Supplement Dates Manufacturer Received: 11/15/2017
• Supplement Dates FDA Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/08/2014
• 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 Age: 35 YR