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

Model Number SC-2218-70

Device Problems Bent (1059); Fracture (1260); Kinked (1339)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/06/2015

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-1132, serial #: (b)(4), description: precision spectra implantable pulse generator.Model #: sc-2218-70, serial #: (b)(4), description: linear st lead 70cm.Model #: sc-2366-50, serial #: (b)(4), description: linear 3-6 lead 50cm.Model #: sc-4316, lot #: 16378049, description: next generation anchor kit sterile the ipg and lead sc-2366-50, s/n (b)(4) passed all tests performed.Analysis of lead sc-2218-70 s/n (b)(4) revealed that the lead was cleanly cut and the damage was a result of a typical explant procedure.Analysis of lead sc-2218-70, s/n (b)(4) revealed that all cables were fractured 1cm from the clik anchor set screw mark.There were no exposed cables.Analysis of lead sc-2366-50 s/n (b)(4) revealed 2 cables were fractured 1 cm from the clik anchor set screw mark.There were no exposed cables.Analysis of clik anchor sc-4316, lot 16378049 revealed a damaged eyelet with missing silicone.The explanting physician cannot recall if the missing piece of silicone was removed from the patient or not.

Event Description

A report was received that the patient underwent a system explant procedure due to a loss of effectiveness for pain control.

• 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: 5033578
• MDR Text Key: 24206964
• Report Number: 3006630150-2015-02146
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: 030017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Report Date: 07/30/2015

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: 03/31/2014
• Device Model Number: SC-2218-70
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: M365SC2218700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2012
• 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