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

Model Number	SC-3138-25
Medical Device Problem Codes	Fracture (1260); Migration (4003)
Health Effect - Clinical Codes	Complaint, Ill-Defined (2331); No Known Impact Or Consequence To Patient (2692)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Model number/catalog number: sc-3138-25.Serial number: (b)(4).Batch/lot number: (b)(4).Model/catalog description: lead extension kit 25cm.
Event or Problem Description
A report was received that during an explant procedure, the lead extension was severed which leaves a sharp tip.It was also reported that the lead extension has migrated and erupted through patients skin.
Additional Manufacturer Narrative
A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.
Event or Problem Description
A report was received that during an explant procedure, the lead extension was severed which leaves a sharp tip.It was also reported that the lead extension has migrated and erupted through patients skin.

• 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: 8450234
• Report Number: 3006630150-2019-01315
• Device Sequence Number: 2977851
• Product Code: LGW
• UDI-Device Identifier: 08714729760542
• UDI-Public: 08714729760542
• Combination Product (Y/N): N
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 03/01/2013
• Device Model Number: SC-3138-25
• Device Catalogue Number: SC-3138-25
• Device Lot Number: 14140040
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/04/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 04/19/2019
• 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: 67 YR