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

Model Number SC-8216-50

Device Problems Bent (1059); Fracture (1260); High impedance (1291); Kinked (1339); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/18/2017

Event Type  Injury  

Manufacturer Narrative

The following devices were returned and analyzed: description: artisan surgical lead, 50cm model#: sc-8216-50 / serial#: (b)(4).Visual inspection found lead tails were bent, kinked, damaged at the clik anchor site.X-ray inspection confirmed 6 cables were fractured (electrodes 1, 2, 3, 4, 7, 13).There are no exposed cables at the clik site fracture.Additionally, one tail is detached from paddle and cables are exposed.The fractured cables resulted in the reported high impedances.Description: next generation anchor kit-sterile model#: sc-4316 / lot#: 19301725.Visual inspection confirmed the clik anchor has a torn eyelet with missing silicone material.It is currently unknown whether the missing silicone was retrieved from the patient¿s body.

Event Description

A report was received that the patient underwent a lead replacement procedure as a result of high impedances with the lead.

Manufacturer Narrative

Sc-8216-50 sn (b)(4), device analysis of the lead revealed that the complaint has been confirmed.Visual inspection found lead tails were bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture locations are 8 cm from the tip of paddle end.X-ray inspection confirmed 6 cables were fractured (electrodes 1, 2, 3, 4, 7, 13).There are no exposed cables at the clik site fracture.The fractured cables resulted in the reported high impedances.Additionally, one tail is cleanly cut.The lumen was pulled and it exposed the cables.The cut damage and pulling of the lumen is a result of a typical explant procedure and it is not considered a failure.Sc-4316 ln 19301725 device analysis of the clik anchor revealed that the clik anchor has a torn eyelet with missing silicone material.The silicone was not left inside the patient.

Event Description

A report was received that the patient underwent a lead replacement procedure as a result of high impedances with the lead.

• Brand Name: PRECISION SPECTRA
• Type of Device: SPINAL CORD SIMULATOR
• 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: 6789142
• MDR Text Key: 82514117
• Report Number: 3006630150-2017-02999
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729779902
• UDI-Public: 08714729779902
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 07/18/2017

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: Physician
• Device Expiration Date: 04/12/2018
• Device Model Number: SC-8216-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2017
• Initial Date FDA Received: 08/11/2017
• Supplement Dates Manufacturer Received: 08/22/2017
• Supplement Dates FDA Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2016
• 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