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	04/30/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Section b3: date of event is estimated.Section d4: lot number, expiration date, primary unique device identification (udi) number is unknown.Section d4: unique device identifier (udi #): the udi is unknown because the lot number was not provided/is unknown.Section h4 - device manufacture date is unknown.
Event or Problem Description
It was reported that patient experienced diminished/loss of therapy due to high impedances on all contacts.Surgical intervention may be undertaken to address this issue.
Additional Manufacturer Narrative
A patient experienced diminished/loss of therapy due to high impedances on all contacts was reported to abbott.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 event could not be conclusively determined.
Additional Manufacturer Narrative
Correction: section b1 ¿ type of report - product problem removed.Correction: section d4 - lot number, expiration date and primary unique device identification (udi) number updated.Correction: section h4 - device manufacture date updated.

• 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
• 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: 19389199
• Report Number: 1627487-2024-08945
• Device Sequence Number: 20771793
• Product Code: LGW
• UDI-Device Identifier: 05414734401784
• UDI-Public: (01)05414734401784(10)5310000(17)171031
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2024

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: 10/31/2017
• Device Model Number: 3214
• Device Catalogue Number: 3214
• Device Lot Number: 5310000
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 07/16/2024; 08/02/2024
• Initial Report FDA Received Date: 05/23/2024
• Supplement Report FDA Received Date: 07/18/2024; 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/30/2015
• 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