MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-3138-35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Unspecified Infection (1930); No Code Available (3191)
Date of Event	11/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved: model # 3138-35, serial #: (b)(4), description: lead extension kit 35 cm.
Event or Problem Description
A report was received that the patient underwent an explant procedure due to infection at the lead extension sites.Liquid was coming out from the extension sites.The patient was placed on anti-biotics.The physician was unsure what caused the infection but said nothing happened during the recent implant procedure that may have caused or contributed to the infection.
Additional Manufacturer Narrative
Record review revealed no additional information related to the complaint, therefore the probable cause selected is "no problem detected".Correction to the initial mdr in field h10.Additional suspect medical device components involved: model # 3138-35 serial #: (b)(6).Description: lead extension kit 35cm.Model # sc-8216-50 serial # (b)(6).Description: artisan 2x8 surgical lead.
Event or Problem Description
A report was received that the patient underwent an explant procedure due to infection at the lead extension sites.Liquid was coming out from the extension sites.The patient was placed on anti-biotics.The physician was unsure what caused the infection but said nothing happened during the recent implant procedure that may have caused or contributed to the infection.

• Brand Name: NA
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 9475465
• Report Number: 3006630150-2019-07378
• Device Sequence Number: 16856768
• Product Code: LGW
• UDI-Device Identifier: 08714729760559
• UDI-Public: 08714729760559
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2020

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: 09/13/2021
• Device Model Number: SC-3138-35
• Device Catalogue Number: SC-3138-35
• Device Lot Number: 5174838
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/27/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 02/11/2020
• 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