MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION PRECISION; SPINAL CORD STIMULATOR

Model Number	SC-1110-02
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/04/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received that the patient was having difficulty charging the ipg.The patient will undergo an ipg replacement procedure.
Additional Manufacturer Narrative
Additional information was received that device malfunction was not confirmed, it was just stated that patient was still not able to charge and that the ipg will be sent in after the procedure.
Event or Problem Description
A report was received that the patient was having difficulty charging the ipg.The patient will undergo an ipg replacement procedure.
Additional Manufacturer Narrative
Additional information was received that the patient underwent an ipg replacement procedure and was doing well postoperatively.The explanted device was not returned to bsn as it was kept by the medical facility.A review of the manufacturing documentation for the device 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 was having difficulty charging the ipg.The patient will undergo an ipg replacement procedure.

• Brand Name: PRECISION
• Common Device Name: SPINAL CORD STIMULATOR
• Manufacturer (Section D): BOSTON SCIENTIFIC NEUROMODULATION; 25155 rye canyon loop; valencia CA 91355
• MDR Report Key: 7456506
• Report Number: 3006630150-2018-01427
• Device Sequence Number: 16487121
• Product Code: LGW
• UDI-Device Identifier: M365SC1110020
• UDI-Public: M365SC1110020
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: 030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/01/2014
• Device Model Number: SC-1110-02
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/01/2018; 06/19/2018
• Initial Report FDA Received Date: 04/24/2018
• Supplement Report FDA Received Date: 05/22/2018; 07/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR