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

Model Number	SC-9208-15E
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Purulent Discharge (1812); Unspecified Infection (1930); Swelling (2091)
Date of Event	11/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that the patient had an infection at the midline incision site.Symptoms of drainage of pus and swelling were noted.It was unknown if infection was device related.The patient was placed on antibiotics.The patient will undergo an explant procedure.
Additional Manufacturer Narrative
A review of the manufacturing documentation for the device revealed that no anomalies or deviations potentially relate to the event occurred during manufacturing.A review of the sterilization documentation for the device was found to be satisfactory.
Event or Problem Description
A report was received that the patient had an infection at the midline incision site.Symptoms of drainage of pus and swelling were noted.It was unknown if infection was device related.The patient was placed on antibiotics.The patient will undergo an explant procedure.

• 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: 8116452
• Report Number: 3006630150-2018-62016
• Device Sequence Number: 1579202
• Product Code: LGW
• UDI-Device Identifier: 08714729893295
• UDI-Public: 08714729893295
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• 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
• Report Date (Section B): 11/11/2019

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: 09/07/2019
• Device Model Number: SC-9208-15E
• Device Catalogue Number: SC-9208-15E
• Device Lot Number: 21077338
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/29/2018
• Supplement Report FDA Received Date: 11/11/2019
• 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
• Patient Age: 69 YR