MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION NO BRAND NAME ON LABEL; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-3138-55
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Erosion (1750)
Date of Event	08/20/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Model number/catalog number: sc-3138-55, serial number: (b)(4), batch/lot number: 21150605/21150605/21150605, model/catalog description: lead extension kit, 55cm.
Event or Problem Description
A report was received that the patients extension hub was very superficial and not buried enough deeper.No skin breakage was reported.The patient underwent a revision procedure wherein the extension was repositioned.The patient was doing well postoperatively.

• Brand Name: NO BRAND NAME ON LABEL
• 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: 7882645
• Report Number: 3006630150-2018-60915
• Device Sequence Number: 1908392
• Product Code: LGW
• UDI-Device Identifier: 08714729760566
• UDI-Public: 08714729760566
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 09/17/2018

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: 09/21/2019
• Device Model Number: SC-3138-55
• Device Catalogue Number: SC-3138-55
• Device Lot Number: 21150605
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2018
• Initial Report FDA Received Date: 09/17/2018
• 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: 52 YR