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

Model Number	SC-2158-50
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: scs-linear leads, model: sc-2158-50, upn: (b)(4), serial: (b)(4), description: linear lead kit 50 cm.
Event or Problem Description
Device analysis performed on 2 returned leads revealed that both leads were fractured: lead sc-2158-50, sn (b)(4) revealed that all cables were completely broken at the bent kinked location of the lead.The bent kinked location is 1 cm from the set screw mark of the clik anchor.There are no exposed cables at the clik site fracture locations.The fractured cables at the clik anchor site resulted in the high impedances.Lead sc-2158-50, sn (b)(4) revealed that three cables were completely broken at the bent kinked location of the lead.The bent kinked location is 1 cm from the set screw mark of the clik anchor.There are no exposed cables at the clik site fracture location.The fractured cables at the clik anchor site resulted in the high impedances.

• Brand Name: LINEAR
• 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: 8475622
• Report Number: 3006630150-2019-01457
• Device Sequence Number: 1303480
• Product Code: LGW
• UDI-Device Identifier: 08714729767695
• UDI-Public: 08714729767695
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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: 07/31/2017
• Device Model Number: SC-2158-50
• Device Catalogue Number: SC-2158-50
• Device Lot Number: 18117908
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1