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

Model Number	SC-1112
Medical Device Problem Codes	Delayed Charge Time (2586); Charging Problem (2892)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient experienced difficulty charging and increased charging frequency of their implantable pulse generator (ipg).Attempts to re-educate the patient on charging techniques did not resolve the issue.The patient underwent a revision procedure where the ipg was replaced and did well postoperatively.
Additional Manufacturer Narrative
Block b3: exact date unknown, event occurred approximately 12 months ago.
Event or Problem Description
It was reported that the patient experienced difficulty charging and increased charging frequency of their implantable pulse generator (ipg).Attempts to reeducate the patient on charging techniques did not resolve the issue.The patient underwent a revision procedure where the ipg was replaced and did well postoperatively.
Additional Manufacturer Narrative
Analysis of the returned ipg revealed the device was successfully fully recharged within a four-hour cycle, and analysis of the device data logs didn't reveal any anomalies related to premature battery depletion.However, the charging log indicated a low charge current, which indicates sub-optimal charging, resulting in low battery voltage and the thermistor being triggered.These are known factors that may contribute to charging difficulty.

• 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: 17574400
• Report Number: 3006630150-2023-04897
• Device Sequence Number: 12828988
• 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: 2019
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2024

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: 11/30/2017
• Device Model Number: SC-1112
• Device Catalogue Number: SC-1112
• Device Lot Number: 18560713
• 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: 08/02/2023
• Supplement Date Received by Manufacturer: 02/01/2024
• Initial Report FDA Received Date: 08/18/2023
• Supplement Report FDA Received Date: 02/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2015
• 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