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

Model Number	SC-5312
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	11/05/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation for the charger revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
Event or Problem Description
A report was received that the patient developed a small blister and experienced a burning sensation while charging.No intervention was provided to address the blister, the patient was provided with proper charging techniques, and will be followed by the field clinical engineer.
Additional Manufacturer Narrative
Additional information was received that the patient developed two blisters.The patient was charging in one hour sessions at which time she developed a large blister, which then subsided.The patient then changed to 45 minute charging sessions which is when the small blister developed.The charger is pending return.
Event or Problem Description
A report was received that the patient developed a small blister and experienced a burning sensation while charging.No intervention was provided to address the blister, the patient was provided with proper charging techniques, and will be followed by the field clinical engineer.
Event or Problem Description
A report was received that the patient developed a small blister and experienced a burning sensation while charging.No intervention was provided to address the blister, the patient was provided with proper charging techniques, and will be followed by the field clinical engineer.Additional information was received that the patient developed two blisters.The patient was charging in one hour sessions at which time she developed a large blister, which then subsided.The patient then changed to 45 minute charging sessions which is when the small blister developed.
Additional Manufacturer Narrative
The returned device was analyzed and no anomalies were found.

• 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
• MDR Report Key: 9434507
• Report Number: 3006630150-2019-07136
• Device Sequence Number: 2424745
• Product Code: LGW
• UDI-Device Identifier: 08714729764465
• UDI-Public: 08714729764465
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/18/2020

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-5312
• Device Catalogue Number: SC-5312
• Device Lot Number: 347821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 12/08/2019; 02/18/2020
• Initial Report FDA Received Date: 12/06/2019
• Supplement Report FDA Received Date: 12/20/2019; 02/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention