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 Code	Burn(s) (1757)
Date of Event	07/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device has not been returned yet.
Event or Problem Description
A report was received that the patient ipg pocket site felt hot while charging.Physician assessed that the patient had a low temperature burn that resulted in a blister.A gauze dressing was applied and patient was advised to discontinue use of the device for one week.
Event or Problem Description
A report was received that the patient ipg pocket site felt hot while charging.Physician assessed that the patient had a low temperature burn that resulted in a blister.A gauze dressing was applied and patient was advised to discontinue use of the device for one week.
Additional Manufacturer Narrative
This is a duplicate report.This complaint was previously reported under report 3006630150-2018-02328.
Event or Problem Description
A report was received that the patient ipg pocket site felt hot while charging.Physician assessed that the patient had a low temperature burn that resulted in a blister.A gauze dressing was applied and patient was advised to discontinue use of the device for one week.

• 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: 7787210
• Report Number: 3006630150-2018-60606
• Device Sequence Number: 227884
• Product Code: LGW
• UDI-Device Identifier: 08714729764465
• UDI-Public: 08714729764465
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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-5312
• Device Catalogue Number: SC-5312
• Device Lot Number: 17152580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 07/25/2018
• Supplement Date Received by Manufacturer: 09/03/2018; 10/05/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 09/28/2018; 10/05/2018
• 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