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

Model Number SC-2316-50

Device Problems Fracture (1260); High impedance (1291); Kinked (1339)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/20/2015

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model #: sc-4316 lot #: 18182693 description: next generation anchor kit-sterile.

Event Description

A report was received that the patient underwent a lead explant procedure due to high impedances.During the procedure the physician noted that the lead appeared to be visually broken just below the clik anchor.The physician observed a deep kink on the lead, but did not observe any exposed wires.The patient was reportedly doing well post operatively.

Manufacturer Narrative

Sc-2316-50 (sn (b)(4)) the complaint has been confirmed.Visual and x-ray inspection of the lead revealed that multiple cables were completely broken at the bent/kinked location of the lead.The bent/kinked locations are 1 cm from both sides of the set screw mark of the clik anchor.There are no exposed cables at the fracture locations.Sc-4316 (ln 18182693) the clik anchor revealed no anomalies.

Event Description

A report was received that the patient underwent a lead explant procedure due to high impedances.During the procedure the physician noted that the lead appeared to be visually broken just below the clik anchor.The physician observed a deep kink on the lead, but did not observe any exposed wires.The patient was reportedly doing well post operatively.

• 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: 5217143
• MDR Text Key: 30985926
• Report Number: 3006630150-2015-02957
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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
• Type of Report: Initial,Followup
• Report Date: 10/20/2015

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: 05/31/2017
• Device Model Number: SC-2316-50
• Device Catalogue Number: N/A
• Device Lot Number: N/A
• Other Device ID Number: M365SC2316500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/20/2015
• Initial Date FDA Received: 11/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2015
• 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