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

Model Number	SC-9218-15
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: sc-9218-15, serial number: (b)(4), batch/lot number: 20142592, model/catalog description: precision m8 adapter 15cm.The explanted devices were not returned to bsn as they were kept by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially relate to the event occurred during the manufacturing.
Event or Problem Description
A report was received that the patients had high impedances.The patient underwent a lead extension replacement and was doing well postoperatively.

• 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: 8687564
• Report Number: 3006630150-2019-02723
• Device Sequence Number: 16731720
• Product Code: LGW
• UDI-Device Identifier: 08714729888734
• UDI-Public: 08714729888734
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/11/2019

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 Expiration Date: 08/16/2018
• Device Model Number: SC-9218-15
• Device Catalogue Number: SC-9218-15
• Device Lot Number: 19591009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2019
• Initial Report FDA Received Date: 06/11/2019
• 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: 77 YR