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

Model Number	SC-1112
Medical Device Problem Codes	Unexpected Therapeutic Results (1631); Charging Problem (2892); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pain (1994)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced inadequate stimulation, and had to charge their spinal cord stimulator (scs) implantable pulse generator (ipg) more frequently.Reprogramming was attempted, however it was not able to resolve the lack of therapy.The patient underwent a revision procedure in which the ipg was replaced, and is doing well post operatively.
Event or Problem Description
It was reported that the patient experienced inadequate stimulation, and had to charge their spinal cord stimulator (scs) implantable pulse generator (ipg) more frequently.Reprogramming was attempted, however it was not able to resolve the lack of therapy.The patient underwent a revision procedure in which the ipg was replaced, and is doing well post operatively.
Additional Manufacturer Narrative
The ipg was returned and analyzed, and passed external visual inspection and was able to be recharged in one four-hour charge cycle.The ipg battery is depleting its' charge within the normal range.However, borescope inspection revealed that spring contact 8 was damaged, and x-ray inspection further confirmed the damaged spring contact.The functional test was unable to be performed due to the damaged contact.The spring contact was likely damaged during the explant procedure.A labeling review was performed on ipg's, instructions for use, ifu.There was no evidence that the device was used in a manner inconsistent with the labeled indications.It states that system failure, which can occur at any time due to random failures of the components or the battery.These events, which may include battery leakage, device failure, lead breakage, hardware malfunctions, loose connections, electrical shorts or open circuits and lead insulation breaches, can result in ineffective pain control and undesirable stimulation may occur over time due to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections and/or lead failure are known risks of implanting a pulse generator as part of a system to deliver spinal cord stimulation.Based on all available information, engineers are able to confirm the root cause of the event.The lead was returned and analyzed, as such physical analysis was conducted, record review revealed no additional information related to the complaint.Therefore, this investigation is able to determine a probable root cause for the complaint and the conclusion is known inherent risk of device.

• 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; 25155 rye canyon loop; valencia CA 91355
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17733151
• Report Number: 3006630150-2023-05499
• Device Sequence Number: 6543316
• 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: 2016
• Device Explanted Year: 2023
• 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
• Report Date (Section B): 01/29/2024

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: 01/26/2018
• Device Model Number: SC-1112
• Device Catalogue Number: SC-1112
• Device Lot Number: 18774747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 09/12/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/26/2016
• 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