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	Burn(s) (1757); Skin Irritation (2076); Fluid Discharge (2686); No Code Available (3191)
Date of Event	07/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: (b)(6) years old.
Event or Problem Description
A report was received that the patient was getting blisters from the charger heat and it was leaking out.
Additional Manufacturer Narrative
Additional information was received that the patient underwent an ipg explant procedure and lead was kept in place to hold space for a future implant (mfr report number: 3006630150-2019-04001).A review of the manufacturing documentation for the device revealed that no anomalies or deviations potentially relate to the event occurred during manufacturing.A review of the sterilization documentation for the device was found to be satisfactory.
Event or Problem Description
A report was received that the patient was getting blisters from the charger heat and it was leaking out.

• 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: 8858162
• Report Number: 3006630150-2019-03991
• Device Sequence Number: 2397689
• Product Code: LGW
• UDI-Device Identifier: 08714729764465
• UDI-Public: 08714729764465
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 08/27/2019

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: 21204654
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/12/2019
• Supplement Date Received by Manufacturer: 08/06/2019
• Initial Report FDA Received Date: 08/02/2019
• Supplement Report FDA Received Date: 08/27/2019
• 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: 61 YR