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

Model Number	SC-5312
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Codes	Rash (2033); Burning Sensation (2146); Partial thickness (Second Degree) Burn (2694)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
A report was received that the patient had blister at back near the ipg site which was described as tender.The patient was prescribed with antibiotics.

• 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: 9756572
• Report Number: 3006630150-2020-00807
• Device Sequence Number: 13999457
• Product Code: LGW
• UDI-Device Identifier: 08714729764465
• UDI-Public: 08714729764465
• Combination Product (Y/N): N
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/26/2020

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: 50224
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/26/2020
• 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
• Patient Age: 55 YR