MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 60CM LENGTH; PERCUTANEOUS LEAD

Model Number	3186
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	12/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.During processing of this complaint, attempts were made to obtain patient¿s weight.Further information was requested but not received.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
Related manufacturer reference number: 1627487-2020-48918; related manufacturer reference number: 1627487-2020-48920.It was reported that patient experienced ineffective therapy.Reportedly, patient had a fall after the implant.Attempts to reprogram were unsuccessful.As a result, surgical intervention was undertaken wherein the leads and ipg were explanted and replaced with a competitor¿s system.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Common Device Name: PERCUTANEOUS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11024703
• Report Number: 1627487-2020-48919
• Device Sequence Number: 11653197
• Product Code: LGW
• UDI-Device Identifier: 05414734405300
• UDI-Public: 05414734405300
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/16/2020

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/28/2015
• Device Model Number: 3186
• Device Catalogue Number: 3722
• Device Lot Number: 3902487
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PERCUTANEOUS LEAD; SCS IPG
• Outcome Attributed to Adverse Event: Other