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 06/29/2015

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model #: sc-2316-50, serial #: (b)(4), description: infinion1x16 perc lead kit-50 cm; model #: sc-3400-30, serial #: (b)(4), description: infinion splitter 2x8 kit (30 cm).

Event Description

A report was received that the patient was experiencing loss of stimulation.It was determined that there were open contacts on the leads.During the patient's revision, it was noted and was checked using the cable that the leads were fractured.The physician suspected device malfunction with the leads due to contacts that were out.The leads were replaced.The patient was reportedly doing well postoperatively.

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-4316, lot #: 17310474, description: next generation anchor kit-sterile.Sc-2316-50 (sn (b)(4)): device evaluation indicated that eleven cables were fractured at the bent/kinked sections of the lead body, at apparent a clik anchor site about 8 inches from the distal tip.No cables were exposed.Sc-2316-50 (sn (b)(4)): device evaluation indicated that all the cables were fractured at the bent/kinked sections of the lead body, at apparent a clik anchor site about 8.5 inches from the distal tip.No cables were exposed.Sc-3400-30 (sn (b)(4)): device evaluation indicated that the devices passed all tests performed.Visual/x-ray inspections and impedance test were performed to ensure the device integrity.No anomalies were found.Sc-4316 (lot# 17310474): device evaluation indicated that one of the clik anchors had a missing eyelet.Additional information was received that the missing eyelet of the clik anchor was retrieved and nothing was remained in the patient¿s body.

Event Description

A report was received that the patient was experiencing loss of stimulation.It was determined that there were open contacts on the leads.During the patient's revision, it was noted and was checked using the cable that the leads were fractured.The physician suspected device malfunction with the leads due to contacts that were out.The leads were replaced.The patient was reportedly 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: 5182254
• MDR Text Key: 29401524
• Report Number: 3006630150-2015-02739
• 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,Followup
• Report Date: 06/29/2015

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: 11/30/2016
• Device Model Number: SC-2316-50
• Other Device ID Number: M365SC2316500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2015
• Initial Date FDA Received: 10/27/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2014
• 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: 76 YR