MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION INFINION 16; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	SC-2316-50E
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/03/2018
Type of Reportable Event	Malfunction
Event or Problem Description
A report was received that during trial procedure the patient accidentally broke the lead.It was also reported that the was completely damaged.The patient underwent a lead pull procedure.

• Brand Name: INFINION 16
• 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: 7728102
• Report Number: 3006630150-2018-60396
• Device Sequence Number: 996540
• Product Code: LGW
• UDI-Device Identifier: M365SC231650E0
• UDI-Public: M365SC231650E0
• Combination Product (Y/N): N
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2018

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: 03/22/2020
• Device Model Number: SC-2316-50E
• Device Catalogue Number: SC-2316-50E
• Device Lot Number: 5038840
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR