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

Model Number	SC-1112
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pocket Erosion (2013); Staphylococcus Aureus (2058); Swelling (2091); No Code Available (3191)
Date of Event	08/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The ipg has not been returned to bsn.A review of the manufacturing documentation for the ipg 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 effacement of the ipg and may have had an underlying staph infection.The patient underwent and ipg explant procedure.
Additional Manufacturer Narrative
Additional information was received that there may have been a low grade infection at the ipg site as the patient was continually having pain and intermittent swelling there.However, microbiology results showed no growth.The patient was also administered amoxicillin for seven days.The event was assessed as not device related.
Event or Problem Description
A report was received that the patient experienced effacement of the ipg and may have had an underlying staph infection.The patient underwent and ipg explant procedure.
Event or Problem Description
A report was received that the patient experienced effacement of the ipg and may have had an underlying staph infection.The patient underwent and ipg explant procedure.
Additional Manufacturer Narrative
Additional information was received that there may have been a low grade infection at the ipg site as the patient was continually having pain and intermittent swelling there.However, microbiology results showed no growth.The patient was also administered amoxicillin for seven days.The event was assessed as not device related.The returned lpg was analyzed, passed all required tests performed, and exhibited normal device characteristics.The root cause of the complaint could not be determined.

• Brand Name: PRECISION
• 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: 8978254
• Report Number: 3006630150-2019-04916
• Device Sequence Number: 14169163
• Product Code: LGW
• UDI-Device Identifier: 08714729837138
• UDI-Public: 08714729837138
• 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: 2015
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/05/2019

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: 01/31/2017
• Device Model Number: SC-1112
• Device Catalogue Number: SC-1112
• Device Lot Number: 17556709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 09/16/2019; 10/23/2019
• Initial Report FDA Received Date: 09/09/2019
• Supplement Report FDA Received Date: 10/07/2019; 11/05/2019
• 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