MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 44 LEAD KIT, 90CM LENGTH; SCS PADDLE LEAD

Model Number	3262
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Codes	Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported high impedances were observed on the patient's c3 lamitrode lead.Reprogramming was performed to provide effective therapy, but the patient may still undergo surgical intervention to address the issue.
Event or Problem Description
Additional information received indicates that the patient underwent surgical intervention during which the lead was explanted and replaced.Effective therapy was established post-operatively.
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.Correction: section h6 health effect clinical code should have been 2388 instead of 4582, and section h6 health effect impact code should hae been 4610 instead of 2199 in the initial report.This correction is reflected in this additional report 2.

• Brand Name: LAMITRODE 44 LEAD KIT, 90CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11566608
• Report Number: 1627487-2021-12623
• Device Sequence Number: 19713245
• Product Code: LGW
• UDI-Device Identifier: 05414734402132
• UDI-Public: 05414734402132
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/09/2021

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: 12/05/2016
• Device Model Number: 3262
• Device Catalogue Number: 3262
• Device Lot Number: 4904233
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/05/2021
• Supplement Date Received by Manufacturer: 03/24/2021; 04/30/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 04/12/2021; 05/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 64