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

Model Number SC-2316-50

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: model#: sc-1132, serial#: (b)(4), description: precision spectra implantable pulse generator.Model#: sc-2316-50, serial#: (b)(4), description: infinion 1x16 perc lead kit-50 cm.Model#: sc-3400-30, serial#: (b)(4), description: infinion splitter 2x8 kit (30 cm).The explanted devices were not returned to bsn as they were kept by the medical facility.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the devices history records will be conducted.If there is any further relevant information from that review, a supplemental med watch will be filed.

Event Description

A report was received that the patients stimulation was not providing adequate coverage as the contacts were not working.The patient underwent an explant procedure.

• 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: 7150132
• MDR Text Key: 95940314
• Report Number: 3006630150-2017-05512
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 08714729797814
• UDI-Public: 08714729797814
• 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
• Report Date: 12/27/2017

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: 07/16/2016
• Device Model Number: SC-2316-50
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2014
• 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 Age: 37 YR