MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE TRIPOLE 16C LEAD, 60 CM; SCS PADDLE LEAD

Model Number	3214
Medical Device Problem Code	Therapeutic or Diagnostic Output Failure (3023)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/14/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event and therapy date are estimated.
Event or Problem Description
Manufacturer reference number:1627487-2021-13658.It was reported that the patient experienced ineffective therapy.As such, surgical intervention took place wherein the entire system was explanted.
Additional Manufacturer Narrative
Corrected data: d6b - date of explant information was inadvertently excluded in the initial report.The information has been included in section d6b of this record.
Additional Manufacturer Narrative
The report of ineffective stimulation was confirmed.Analysis of the lead found it was returned in segments, cut as a result of the explant procedure.Microscopic inspection found two broken wires at channel one and channel 11 in the paddle segment.These fractures are consistent with an overstress condition or sudden event the lead was subjected to while still in vivo.

• Brand Name: LAMITRODE TRIPOLE 16C LEAD, 60 CM
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11767779
• Report Number: 1627487-2021-13659
• Device Sequence Number: 19605796
• Product Code: LGW
• UDI-Device Identifier: 05415067017789
• UDI-Public: 05415067017789
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/25/2021

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: 05/31/2017
• Device Model Number: 3214
• Device Catalogue Number: 3214
• Device Lot Number: 5132490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 06/15/2021; 06/15/2021
• Initial Report FDA Received Date: 05/04/2021
• Supplement Report FDA Received Date: 06/24/2021; 06/25/2021
• 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: SCS IPG, MODEL 3662; SCS IPG, MODEL 3662
• Outcome Attributed to Adverse Event: Other