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

Model Number	SC-3138-25
Medical Device Problem Codes	High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	04/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: sc-3138-25; serial number: 1082435; batch/lot number: 19340714; model/catalog description: lead extension kit 25cm.The explanted devices were not returned to bsn.A review of the manufacturing documentation for the lead extensions revealed that no anomalies or deviations potentially relate to the event occurred during manufacturing.
Event or Problem Description
A report was received that the patient was experiencing inadequate stimulation due to high impedance.The patient underwent a revision procedure wherein the lead extensions were replaced.The patient was doing well postoperatively.

• 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: 9092881
• Report Number: 3006630150-2019-05186
• Device Sequence Number: 2528326
• Product Code: LGW
• UDI-Device Identifier: 08714729760542
• UDI-Public: 08714729760542
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/19/2019

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: 06/08/2018
• Device Model Number: SC-3138-25
• Device Catalogue Number: SC-3138-25
• Device Lot Number: 19340714
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/19/2019
• 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: 65 YR