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

Model Number	SC-3138-25
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Wound Dehiscence (1154); Bacterial Infection (1735)
Date of Event	09/27/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs- extension, upn: m365sc3138350, model: sc-3138-35, serial: (b)(4).Additional suspect medical device component involved in the event: product family: scs- ipg-r-mri, upn: m365sc12320, model: sc-1232, serial: (b)(4).
Event or Problem Description
It was reported that following a trial perm implant procedure the patient was having an infection.Symptom of open wound was noted.The infection was not device related but physician felt it may spread to device and the physician was unaware that the procedure contributed to infection.The patient was placed on antibiotics and underwent a revision procedure wherein the ipg was explanted and the tail of the leads were cut leaving the electrode portion in place to keep open for revision.The patient was sent to rehabilitation facility for recovery and was doing well postoperatively.The explanted products were sent to laboratory for culture.

• 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: 12687674
• Report Number: 3006630150-2021-05962
• Device Sequence Number: 14459994
• Product Code: LGW
• UDI-Device Identifier: 08714729760542
• UDI-Public: 08714729760542
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2021

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: 02/10/2023
• Device Model Number: SC-3138-25
• Device Catalogue Number: SC-3138-25
• Device Lot Number: 7035253
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/25/2021
• 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: 72 YR