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

Model Number SC-8216-70

Device Problems Kinked (1339); Material Separation (1562)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/01/2018

Event Type  malfunction  

Event Description

A report was received that the patient was experiencing lack of coverage.It was noted that x-ray shows a paddle migration to c5 and 2 kinked contacts which are dislodged.The patient underwent a lead replacement procedure.No device malfunction was suspected.The patient was doing well postoperatively.

Manufacturer Narrative

A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially relate to the event occurred during the manufacturing.

Event Description

A report was received that the patient was experiencing lack of coverage.It was noted that x-ray shows a paddle migration to c5 and 2 kinked contacts which are dislodged.The patient underwent a lead replacement procedure.No device malfunction was suspected.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: 7368139
• MDR Text Key: 103425804
• Report Number: 3006630150-2018-01141
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729779919
• UDI-Public: 08714729779919
• Combination Product (y/n): N
• 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: 04/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2018
• Device Model Number: SC-8216-70
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2016
• 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