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

Model Number	SC-3138-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Edema (1820); Pain (1994)
Date of Event	03/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: model#: sc-3138-25, serial#: (b)(4), description: scs phiii ext 25cm.
Event or Problem Description
A report was received that the patient was experiencing pain at the midline incision site that was aggravated when the stimulation was turned high.Swelling was also noted at the incision site.The physician believed that the symptoms were due to the extension leads.The patient will undergo a lead extension revision procedure.
Additional Manufacturer Narrative
Additional information was received that there will be no further course of action at this time.
Event or Problem Description
A report was received that the patient was experiencing pain at the midline incision site that was aggravated when the stimulation was turned high.Swelling was also noted at the incision site.The physician believed that the symptoms were due to the extension leads.The patient will undergo a lead extension revision procedure.
Additional Manufacturer Narrative
Additional information was received that the patient will undergo a lead replacement procedure.
Event or Problem Description
A report was received that the patient was experiencing pain at the midline incision site that was aggravated when the stimulation was turned high.Swelling was also noted at the incision site.The physician believed that the symptoms were due to the extension leads.The patient will undergo a lead extension revision procedure.

• 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: 7360537
• Report Number: 3006630150-2018-01125
• Device Sequence Number: 2024085
• Product Code: LGW
• UDI-Device Identifier: 08714729760542
• UDI-Public: 08714729760542
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2018

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: 08/09/2019
• Device Model Number: SC-3138-25
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 04/04/2018; 05/03/2018
• Initial Report FDA Received Date: 03/21/2018
• Supplement Report FDA Received Date: 04/24/2018; 05/23/2018
• 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
• Patient Age: 35 YR