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 07/17/2015

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit(30cm).Sc-2316-50, (sn (b)(4)), all sixteen cables were fractured at the bent/kinked sections of the lead body, at apparent a click anchor site about 8 inches from the distal tip.The lead body was sharply bent at the end of the proximal.No cables were exposed.Sc-3400-30 (sn (b)(4)) device evaluation indicated that the splitter passed all performed test.Visual/x-ray inspections and impedance measurements were performed to ensure the device integrity.No anomalies were found.Sc-3400-30 (sn (b)(4)) as no anomalies or deviations were found during the complaint investigation site (cis) review, there is no reason to suspect a manufacturing defect as the source of the reported complaint.

Event Description

A report was received that the patient was experiencing loss of stimulation.It was determined that the lead contacts inside the splitter were not lining up and this had caused abnormal impedances.Imaging showed a possible loss of connection.The patient underwent a procedure wherein the physician lined up the contacts and re-tested but was unable to successfully achieved connection.The lead and splitter were replaced.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: 5117426
• MDR Text Key: 27237384
• Report Number: 3006630150-2015-02498
• 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
• Report Date: 07/20/2015

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: 11/30/2015
• Device Model Number: SC-2316-50
• Other Device ID Number: M365SC2316500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/16/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2013
• 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: 63 YR