MAUDE Adverse Event Report: ABBOTT MEDICAL OCTRODE LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number	3189
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient's ipg became inoperable due to not recharging as recommended.It was also noted that one of the patient's cervical leads had high impedances on all contacts.As a result, the patient may undergo surgical intervention to address the issue.It is unknown which lead had the high impedances.
Additional Manufacturer Narrative
Date of event is estimated.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.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: octrode lead, model: 3186ans, serial: (b)(6), udi: (b)(4), batch: a000126154.
Event or Problem Description
Additional information was received stating the lead was already reported on (manufacturer report number: 1627487-2024-11690) and the lead device information was corrected,.
Additional Manufacturer Narrative
Date of event estimated.Correction - section d - lead device information corrected.Correction - section b5 - lead was already reported on manufacturer report number 1627487-2024-11690.

• Brand Name: OCTRODE LEAD KIT, 90CM LENGTH
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; santana industrial park; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 20601421
• Report Number: 3006705815-2024-08335
• Device Sequence Number: 21068626
• Product Code: LGW
• UDI-Device Identifier: 05414734406147
• UDI-Public: (01)05414734406147(10)5006972(17)170131
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024

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: 01/31/2017
• Device Model Number: 3189
• Device Catalogue Number: 3189
• Device Lot Number: 5006972
• 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: 10/16/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 11/04/2024
• Supplement Report FDA Received Date: 12/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2022
• 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; SCS IPG; SCS LEAD; SCS LEAD; SCS LEADS (X2)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Patient Weight: 59 KG