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

Model Number	SC-9208-15E
Medical Device Problem Codes	Break (1069); Fracture (1260); High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Model number/catalog number: sc-9208-15e; serial number: (b)(4); batch/lot number: 20119092; model/catalog description: precision s8 trial adapter 15cm.
Event or Problem Description
A report was received that the patients lead had been broken.
Additional Manufacturer Narrative
Additional information was received that patient had a competitors lead that was linked up using bsc s8 adapter.The impedances were very high resulting in poor coverage.The physician did not suspect device malfunction and this was unrelated to our device.
Event or Problem Description
A report was received that the patients lead had been broken.

• 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: 7852547
• Report Number: 3006630150-2018-60833
• Device Sequence Number: 13912286
• Product Code: LGW
• UDI-Device Identifier: 08714729893295
• UDI-Public: 08714729893295
• Combination Product (Y/N): N
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/12/2018

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: 01/05/2019
• Device Model Number: SC-9208-15E
• Device Catalogue Number: SC-9208-15E
• Device Lot Number: 20119092
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 10/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR