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

Model Number	SC-6412-3
Medical Device Problem Codes	Overheating of Device (1437); Charging Problem (2892)
Health Effect - Clinical Codes	Burn(s) (1757); Discomfort (2330); Skin Inflammation/ Irritation (4545)
Date of Event	07/27/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.
Event or Problem Description
It was reported that the patient suffered a burn from the charger.It was noted that the patient charged for two hours and at the end of the charging session, the charging puck was very hot to touch and had ripped off the patients skin when it was removed.
Event or Problem Description
It was reported that the patient suffered a burn from the charger.It was noted that the patient charged for two hours and at the end of the charging session, the charging puck was very hot to touch and had ripped off the patients skin when it was removed.Additional information was received that the patient was experiencing difficulty in charging and discomfort while charging the ipg.It was also mentioned that the patient had irritation on the skin while charging and was advised to contact a local physician.

• 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; 4100 hamline avenue north; saint paul MN 55112 5798
• Manufacturer Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 15250777
• Report Number: 3006630150-2022-04141
• Device Sequence Number: 17765622
• Product Code: LGW
• UDI-Device Identifier: 08714729821243
• UDI-Public: 08714729821243
• Combination Product (Y/N): N
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 09/21/2022

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 Model Number: SC-6412-3
• Device Catalogue Number: SC-6412-3
• Device Lot Number: 340212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Supplement Date Received by Manufacturer: 08/30/2022
• Initial Report FDA Received Date: 08/18/2022
• Supplement Report FDA Received Date: 09/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female