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

Model Number	SC-3138-55
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model # sc-3138-55, serial (b)(4), description: scs phiii ext 55 cm.The explanted devices were not returned to bsn as they were discarded by the medical facility.
Event or Problem Description
A report was received that the patient was experiencing inadequate stimulation.The physician decided to explant two leads in order to change the patients current therapy strategy.Per the physicians assessment device malfunction is not suspected.The patient is doing well post-operatively.
Additional Manufacturer Narrative
Additional information was received that three lead extensions were explanted during the procedure, not two leads.Additional suspect medical device component involved in the event: model: sc-3138-55 serial: (b)(4) description: scs phiii ext 55cm.
Event or Problem Description
A report was received that the patient was experiencing inadequate stimulation.The physician decided to explant two leads in order to change the patients current therapy strategy.Per the physicians assessment device malfunction is not suspected.The patient is doing well post-operatively.
Additional Manufacturer Narrative
Additional information was received that the patients need for new therapy was to address pre-existing pain that was not being covered by the previously implanted leads.
Event or Problem Description
A report was received that the patient was experiencing inadequate stimulation.The physician decided to explant two leads in order to change the patients current therapy strategy.Per the physicians assessment device malfunction is not suspected.The patient is doing well post-operatively.

• Brand Name: PRECISION SPECTRA
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7232001
• Report Number: 3006630150-2018-00446
• Device Sequence Number: 1090554
• Product Code: LGW
• UDI-Device Identifier: 08714729760566
• UDI-Public: 08714729760566
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/19/2018

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?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 10/30/2014
• Device Model Number: SC-3138-55
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 02/07/2018; 03/01/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 02/27/2018; 03/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention