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

Model Number SC-2316-50

Device Problems Fracture (1260); Kinked (1339)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/02/2015

Event Type  Injury  

Manufacturer Narrative

Device evaluation indicated that the lead was pulled and cut during the explant procedure, and the proximal end was not returned.The lead had a pronounced kink at the clik anchor site, 1 cm from the set screw mark.Visual and x-ray inspections revealed that all cables were fractured at the kinked section of the lead.There were no exposed cables.There was no report regarding impedance anomalies.

Event Description

A report was received that during device evaluation, the lead revealed to be fractured.

• 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: 5247288
• MDR Text Key: 32052501
• Report Number: 3006630150-2015-03014
• Device Sequence Number: 1
• Product Code: LGW
• 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
• Report Date: 11/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2016
• Device Model Number: SC-2316-50
• Other Device ID Number: M365SC2316500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 11/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 42 YR