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

Model Number	SC-6412-3
Medical Device Problem Codes	Defective Alarm (1014); Failure to Charge (1085); Overheating of Device (1437)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patients charger was too hot that it burned her.
Additional Manufacturer Narrative
Sc-6412-3 ((b)(6)).The returned charger was analyzed and with all the available information, boston scientific concludes the reported event was confirmed.The charger was not functional due to a blown fuse (f1) and a burnt diode (d2).The blown fuse (f1) and a burnt diode (d2) were likely due to an unexpected over voltage condition.No instances of overheating were observed when the charger was monitored for four hours while placed in the base station.
Event or Problem Description
It was reported that the patients charger was too hot that it burned her.
Event or Problem Description
It was reported that the patient's charger was too hot that it burned her.
Event or Problem Description
It was reported that the patients charger was too hot that it burned her.
Additional Manufacturer Narrative
This report is being submitted to correct the unique identifier (udi) # field (d4) in section d, suspect medical device.

• 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; 4100 hamline avenue north; saint paul MN 55112 -579
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 19642343
• Report Number: 3006630150-2024-04219
• Device Sequence Number: 8609950
• Product Code: LGW
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/20/2026

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 Model Number: SC-6412-3
• Device Catalogue Number: SC-6412-3
• Device Lot Number: 437354
• Date Returned to Manufacturer: 06/24/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2024
• Supplement Date Received by Manufacturer: 07/23/2024; 06/05/2025; 05/20/2026
• Initial Report FDA Received Date: 07/01/2024
• Supplement Report FDA Received Date: 08/13/2024; 06/30/2025; 05/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Female