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

Model Number	3288
Medical Device Problem Codes	Material Fragmentation (1261); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unique device identifier (udi #): the udi is unknown because the lot number was not provided.
Event or Problem Description
Related manufacturer reference number: 1627487-2022-06689.It was reported that during an ipg explant procedure the physician cut the leads.The cut portion of the leads remain implanted in the patient.Surgical intervention may be pending.
Additional Manufacturer Narrative
The reported issue for ¿infection¿ cannot be confirmed through product analysis or testing.Analysis of lead a found it was incomplete, only the terminal end segment was returned.Continuity was checked and no opens were found, setscrew engagement marks were observed.Images were taken to record as received condition.
Additional Manufacturer Narrative
The reported issue for ¿infection¿ cannot be confirmed through product analysis or testing.Analysis of lead a found it was incomplete, only the terminal end segment was returned.Continuity was checked and no opens were found, setscrew engagement marks were observed.Images were taken to record as received condition.

• Brand Name: OCTRODE LEAD KIT, 60CM 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 15934106
• Report Number: 1627487-2022-06688
• Device Sequence Number: 20466958
• Product Code: LGW
• UDI-Device Identifier: 05414734402248
• UDI-Public: 05414734402248
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/29/2023

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: 07/16/2022
• Device Model Number: 3288
• Device Catalogue Number: 3288
• Device Lot Number: 7585575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 12/28/2022; 12/28/2022; 08/29/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 01/05/2023; 01/16/2023; 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown