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	Granuloma (1876); Unspecified Infection (1930); Skin Irritation (2076); No Code Available (3191)
Date of Event	02/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-extension.Upn: (b)(4), model: sc-3138-35, serial: (b)(4), batch: 19276038.
Event or Problem Description
A report was received that the patient experienced skin irritation over the lead extensions from the time they were implanted.The skin irritation turned into a granuloma, increased in size, and became infected.The patient was administered antibiotics and underwent a system explant procedure.The patient is stable post operatively.
Additional Manufacturer Narrative
The explanted device was not returned to bsn as it was lost in transit.A review of the manufacturing documentation for the device revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
Event or Problem Description
A report was received that the patient experienced skin irritation over the lead extensions from the time they were implanted.The skin irritation turned into a granuloma, increased in size, and became infected.The patient was administered antibiotics and underwent a system explant procedure.The patient is stable post operatively.

• 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: 9112022
• Report Number: 3006630150-2019-05266
• Device Sequence Number: 3069696
• Product Code: LGW
• UDI-Device Identifier: 08714729760559
• UDI-Public: 08714729760559
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• 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): 11/07/2019

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: 05/19/2018
• Device Model Number: SC-3138-35
• Device Catalogue Number: SC-3138-35
• Device Lot Number: 19276038
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 09/24/2019
• Supplement Report FDA Received Date: 11/07/2019
• 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