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

Model Number SC-2218-50

Device Problems Bent (1059); Break (1069); High impedance (1291); Kinked (1339)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device component involved in the event: model#: sc-2218-50 serial #: (b)(4) description: linear st lead, 50cm.

Event Description

A report was received that the patient was not getting coverage due to contacts being out.The patient underwent a revision procedure wherein the leads were replaced.The patient was doing well postoperatively.

Manufacturer Narrative

Sc-2218-50 (sn (b)(4)): device evaluation indicated that the lead complaint of high impedances was confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location was 26 cm from the distal end.Cables were not exposed at the clik anchor fracture site.X-ray inspection confirmed 6 cables were fractured (electrodes 1-3, 5, 6,8) at the bent/kinked section of the lead.The fractured cables resulted in the reported high impedances.Sc-2218-50 (sn (b)(4)): device evaluation indicated that the lead complaint of high impedances was confirmed.Visual inspection found lead body was bent/kinked/damaged at the clik anchor site, 1 cm from the set screw mark.The fracture location was 26 cm from the distal end.A cable is exposed at 7 cm from proximal end.X-ray inspection confirmed 7 cables were fractured (electrodes 1-4, 5, 6-8) at the bent/kinked section of the lead.The fractured cables resulted in the reported high impedances.Sc-4316 (ln 18086905): device evaluation indicated that the clik anchor eyelets were torn; there was no missing silicone material.Sc-4316 (ln:18086905) the device evaluation indicated that the eyelets were torn, and there was no missing silicone material.

Event Description

A report was received that the patient was not getting coverage due to contacts being out.The patient underwent a revision procedure wherein the leads were replaced.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: 7122373
• MDR Text Key: 95002273
• Report Number: 3006630150-2017-05183
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729767725
• UDI-Public: 08714729767725
• 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: 01/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/09/2017
• Device Model Number: SC-2218-50
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2015
• 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
• Patient Age: 54 YR