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

Model Number	SC-3138-55
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Discomfort (2330); Inadequate Pain Relief (2388); No Code Available (3191)
Date of Event	03/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional suspect medical device components involved in the event: product family: scs-extension, upn: (b)(4), model: sc-3138-55, serial: (b)(4), batch: 20925951.Product family: scs-linear leads, (b)(4), batch: 20759445.Product family: scs-linear leads, upn: (b)(4), model: sc-2352-50, serial: (b)(4), batch: 20903786.
Event or Problem Description
A report was received that the patient experienced inadequate and uncomfortable stimulation due to high impedances on the leads and lead extensions.The patient underwent a revision procedure where two lead extensions were replaced as they had more impedances than the leads.The patient is doing well postoperatively.
Additional Manufacturer Narrative
Device analysis for the returned lead extensions- lead extension sc-3138-55, sn (b)(4) the complaint of high impedance was confirmed.Analysis of the lead extension revealed cables 1, 5, 6, 7 and 8 were fractured after the weld in the distal connector stack.This type of damage typically occurs when excessive tensile force is exerted onto the lead body and connector section of the lead.Bending the distal end could also cause cable fractures in the connector section of the lead.The broken cables are still contained inside the connector.Lead extension sc-3138-55, sn (b)(4) the complaint of high impedance was confirmed.Analysis of the lead extension revealed cables 6, 7 and 8 were fractured after the weld in the distal connector stack.This type of damage typically occurs when excessive tensile force is exerted onto the lead body and connector section of the lead.Bending the distal end could also cause cable fractures in the connector section of the lead.The broken cables are still contained inside the connector.
Event or Problem Description
A report was received that the patient experienced inadequate and uncomfortable stimulation due to high impedances on the leads and lead extensions.The patient underwent a revision procedure where two lead extensions were replaced as they had more impedances than the leads.The patient is 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: 8484895
• Report Number: 3006630150-2019-01481
• Device Sequence Number: 1723874
• Product Code: LGW
• UDI-Device Identifier: 08714729760566
• UDI-Public: 08714729760566
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: P030017
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2019

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?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 07/27/2019
• Device Model Number: SC-3138-55
• Device Catalogue Number: SC-3138-55
• Device Lot Number: 20925951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2019
• Initial Date Received by Manufacturer: 03/22/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 04/04/2019
• Supplement Report FDA Received Date: 05/09/2019
• 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