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

Model Number	3214
Medical Device Problem Code	Impedance Problem (2950)
Health Effect - Clinical Codes	Failure of Implant (1924); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported that patients lead had high impedances.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein lead was explanted and replaced to address the issue.
Additional Manufacturer Narrative
Correction b5- should have been patients lead had invalid impedances rather than patients lead had high impedances.Correction h6- 4582 - health effect - clinical code should have been 2388 - inadequate pain relief and 1924 - failure of implant rather than 4582 - no clinical signs, symptoms or conditions.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
It was reported that patients lead had invalid impedances.As a result, surgical intervention was undertaken on (b)(6) 2024 wherein lead was explanted and replaced to address the issue.

• Brand Name: LAMITRODE TRIPOLE 16C LEAD, 60 CM
• Common Device Name: SCS 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: 19294288
• Report Number: 1627487-2024-08632
• Device Sequence Number: 7142799
• Product Code: LGW
• UDI-Device Identifier: 05414734401784
• UDI-Public: (01)05414734401784(10)5532464(17)161031
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2024
• 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): 06/04/2024

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: 10/31/2016
• Device Model Number: 3214
• Device Lot Number: 5532464
• 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: 04/18/2024
• Supplement Date Received by Manufacturer: 05/28/2024
• Initial Report FDA Received Date: 05/10/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/08/2016
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 51 YR
• Patient Sex: Male
• Patient Weight: 102 KG