MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION OCTRODE LEAD KIT, 30CM LENGTH; PERCUTANEOUS LEAD

Model Number	3183
Medical Device Problem Codes	Fracture (1260); High impedance (1291); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.The results/ method and conclusion codes along with investigation results will be provided in the final report.Further information was requested but not obtained.
Event or Problem Description
It was reported that the patient lost therapy and the ipg turned off.Diagnostics showed high impedance and x-ray confirmed a kink on the lead.Reprogramming was unable to resolve the issue.In turn, surgical intervention took place on (b)(6) 2020 wherein the lead was explanted and replaced with a new lead resolving the issue.Reportedly, therapy was confirmed post operatively.Note: the reported lead was implanted in (b)(6) 2015.Exact implant date is unknown.
Additional Manufacturer Narrative
Additional information: implant date, device return date.
Additional Manufacturer Narrative
Return octrode lead body had a kink with all internal wires broken which can cause the reported event.The cause of the fracture is consistent with an overstress condition or sudden event the lead was subjected while in vivo.

• Brand Name: OCTRODE LEAD KIT, 30CM LENGTH
• Common Device Name: PERCUTANEOUS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10597662
• Report Number: 1627487-2020-31527
• Device Sequence Number: 19153181
• Product Code: LGW
• UDI-Device Identifier: 05415067017420
• UDI-Public: 05415067017420
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/17/2020

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: Health Professional
• Device Expiration Date: 10/28/2016
• Device Model Number: 3183
• Device Catalogue Number: 3183
• Device Lot Number: 4815024
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 10/08/2020; 11/11/2020
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 10/21/2020; 11/17/2020
• 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: Other