MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE S-8 LEAD KIT, 90CM LENGTH; SCS PADDLE LEAD

Model Number	3268
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
Related manufacturer reference number: 1627487-2022-05224.It was reported x-rays were taken and showed that 1 tail from a lead was disconnected from ipg header.Lead diagnostics showed that all impedances were normal.During revision surgery it was confirmed that one lead from the 16 channel paddle is being used.It was unclear as to whether the second tail connected to ipg header is from the 8 channel lead or 16 channel paddle lead.However, the same lead tails were inserted back into the new ipg header and the third tail was left unplugged.Effective therapy was restored.
Additional Manufacturer Narrative
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.

• Brand Name: LAMITRODE S-8 LEAD KIT, 90CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15481737
• Report Number: 1627487-2022-05204
• Device Sequence Number: 20570922
• Product Code: LGW
• UDI-Device Identifier: 05414734402194
• UDI-Public: 05414734402194
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2022

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: 06/28/2012
• Device Model Number: 3268
• Device Catalogue Number: 3268
• Device Lot Number: 3143322
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2022
• Supplement Date Received by Manufacturer: 09/28/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS IPG(1)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male
• Patient Weight: 82 KG