MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE S-4 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number	3246
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Related manufacturer reference number: 1627487-2020-49229, 1627487-2020-49230.It was reported the patient underwent surgical intervention on (b)(6) 2020 to address an inoperable ipg issue.(reference reg report: 3006705815-2020-30556) during the procedure, diagnostics showed high impedance on multiple contacts.In turn, the patient's leads and extensions were explanted and replaced to address the issue.
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-4 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11076248
• Report Number: 1627487-2020-49231
• Device Sequence Number: 3561132
• Product Code: LGW
• UDI-Device Identifier: 05414734402095
• UDI-Public: 05414734402095
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: 04/28/2014
• Device Model Number: 3246
• Device Catalogue Number: 3246
• Device Lot Number: 3685161
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 12/28/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SCS EXTENSION; SCS LEAD; SCS EXTENSION.; SCS LEAD.
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 105