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

Model Number	SC-9218-15
Medical Device Problem Codes	High impedance (1291); Overheating of Device (1437); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent an implant procedure; high impedances were discovered and stimulation was not providing adequate relief.After the procedure, the physician assessed that the competitors lead or the boston scientific adapter might be the cause of the high impedance readings and therefore, the patient underwent a revision procedure to have them removed and implant boston scientific leads instead.During this revision procedure, there was communication difficulty between the implantable pulse generator (ipg) and the remote control and clinician programmer (cp).Therefore, the physician replaced the ipg intraoperatively.Additionally, it was noted that the replaced ipg felt overheated.The patient is doing well postoperatively.The adapter will not be returned as it was discarded.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-ipg-pc.Upn: m365sc14160.Model: sc-1416.Serial: (b)(6).Batch: 227878.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent an implant procedure; high impedances were discovered and stimulation was not providing adequate relief.After the procedure, the physician assessed that the competitors lead or the boston scientific adapter might be the cause of the high impedance readings and therefore, the patient underwent a revision procedure to have them removed and implant boston scientific leads instead.During this revision procedure, there was communication difficulty between the implantable pulse generator (ipg) and the remote control and clinician programmer (cp).Therefore, the physician replaced the ipg intraoperatively.Additionally, it was noted that the replaced ipg felt overheated.The patient is doing well postoperatively.The adapter will not be returned as it was discarded.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-ipg-pc upn: m365sc14160 model: sc-1416 serial: (b)(6) batch: 227878.Device analysis performed on the returned ipg revealed that the case was swollen due to an enlarged battery and communication could not be established with a known working rc or cp.Functional testing was unable to be performed and the data logs were unable to be retrieved.The ipg was then cut open and revealed a high sleep current and lower than expected resistance, indicating a damaged application specific integrated circuit (asic) chip.This damaged asic is typical of exposure to high voltage transients and high current sources such as electrocautery.A product labeling review was performed which determined that electrocautery may turn stimulation off or may cause permanent damage to the device, particularly if used in close proximity, as documented in the instructions for use (ifu).Therefore, electrocautery use that may have been performed on the patient is likely the cause of the reported event.
Additional Manufacturer Narrative
Additional information provided in block b5.Corrections to block h6.Additional suspect medical device component involved in the event: product family: scs-ipg-pc, upn: m365sc14160, model: sc-1416, serial/batch: 227878.Device analysis performed on the returned ipg revealed that the case was swollen due to an enlarged battery and communication could not be established with a known working rc or cp.Functional testing was unable to be performed and the data logs were unable to be retrieved.The ipg was then cut open and revealed a high sleep current and lower than expected resistance, indicating a damaged application specific integrated circuit (asic) chip.This damaged asic is typical of exposure to high voltage transients and high current sources such as electrocautery.A product labeling review was performed which determined that electrocautery may turn stimulation off or may cause permanent damage to the device, particularly if used in close proximity, as documented in the instructions for use (ifu).Therefore, electrocautery use that was performed on the patient is likely the cause of the reported event.
Event or Problem Description
It was reported that the spinal cord stimulation (scs) patient underwent an implant procedure; high impedances were discovered and stimulation was not providing adequate relief.After the procedure, the physician assessed that the competitors lead or the boston scientific adapter might be the cause of the high impedance readings and therefore, the patient underwent a revision procedure to have them removed and implant boston scientific leads instead.During this revision procedure, there was communication difficulty between the implantable pulse generator (ipg) and the remote control and clinician programmer (cp).Therefore, the physician replaced the ipg intraoperatively.Additionally, it was noted that the replaced ipg felt overheated.The patient is doing well postoperatively.The adapter will not be returned as it was discarded.Additional information was received that confirmed the use of electrocautery during the revision procedure.

• Brand Name: PRECISION
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION CORPORATION; 25155 rye canyon loop; valencia CA 91355
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 20316454
• Report Number: 3006630150-2024-06426
• Device Sequence Number: 12670132
• Product Code: LGW
• UDI-Device Identifier: 08714729888734
• UDI-Public: 08714729888734
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/29/2025

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 08/02/2025
• Device Model Number: SC-9218-15
• Device Catalogue Number: SC-9218-15
• Device Lot Number: 7077347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 12/10/2024; 01/14/2025
• Initial Report FDA Received Date: 09/26/2024
• Supplement Report FDA Received Date: 01/02/2025; 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown