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

Model Number	SC-9218-15
Medical Device Problem Codes	Fracture (1260); Inappropriate/Inadequate Shock/Stimulation (1574)
Health Effect - Clinical Codes	Undesired Nerve Stimulation (1980); Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-adapters.Upn: m365sc9218150.Model: sc-9218-15.Serial: (b)(4).Batch: 7071594.
Event or Problem Description
It was reported that the patient was experiencing overstimulation due to microfracture from the leads which was confirmed via x-ray.It was noted that the patient has a non-boston scientific leads.
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-ipg-r.Upn: m365sc11600.Model: sc-1160.Serial: (b)(6).Batch: 372402.
Event or Problem Description
It was reported that the patient was experiencing overstimulation due to microfracture from the leads which was confirmed via x-ray.It was noted that the patient has a non-boston scientific lead.Additional information was received that the patient experienced pain.The patient underwent a revision procedure wherein the ipg was replaced, and the adapter was explanted.It was noted that there were no microfracture present on the adapter.The patient was doing well postoperatively, and the explanted adapter was kept by the medical facility.
Event or Problem Description
It was reported that the patient was experiencing overstimulation due to microfracture from the leads which was confirmed via x-ray.It was noted that the patient has a non-boston scientific lead.Additional information was received that the patient underwent a revision procedure wherein the ipg was replaced, and the adapter was explanted.It was noted that there are no microfracture and high impedances present on the adapter.The patient was doing well postoperatively, and the explanted adapter was kept by the medical facility.
Additional Manufacturer Narrative
Sc-1160 sn: (b)(4).The returned ipg was analyzed and passed visual inspection.The ipg was able to be fully charged in one four-hour charge cycle.With all the available information, boston scientific concludes the reported event was not confirmed.A full analysis was not able to be performed due to the electrocautery damage to the ipg.However, a labelling review found that the reported event is a known risk of implanting a pulse generator as part of a system to deliver spinal cord stimulation.The ipg is most likely damaged by electrocautery during the explant procedure.The damage to the ipg is a result of a typical explant procedure and it is not considered a failure.Per the physicians implant manual, electrocautery is a known source of high voltage transient signal and warns against the use of electrocautery.

• 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
• 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: 15305650
• Report Number: 3006630150-2022-04304
• Device Sequence Number: 12352656
• Product Code: LGW
• UDI-Device Identifier: 08714729888734
• UDI-Public: 08714729888734
• 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: 2020
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2023

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: 09/24/2022
• Device Model Number: SC-9218-15
• Device Catalogue Number: SC-9218-15
• Device Lot Number: 7071552
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 11/30/2022; 03/10/2023
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 12/21/2022; 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/24/2020
• 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 Age: 60 YR
• Patient Sex: Male