MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 44C LEAD KIT, 60CM LENGTH; SCS PADDLE LEAD

Model Number	3245
Medical Device Problem Codes	Failure to Deliver Energy (1211); High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.
Event or Problem Description
It was reported the patient's system was autoreducing.High impedances were observed on the patient's leads.Reprogramming was unable to resolve the issue.As a result, the patient may 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.
Event or Problem Description
Additional information received indicates that 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.
Additional Manufacturer Narrative
Correction: section e initial reporter has been updated to the correct physician and location.

• Brand Name: LAMITRODE 44C LEAD KIT, 60CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11839028
• Report Number: 1627487-2021-13976
• Device Sequence Number: 14367775
• Product Code: LGW
• UDI-Device Identifier: 05414734402088
• UDI-Public: 05414734402088
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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,Followup,Followup
• Report Date (Section B): 08/17/2021

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 Model Number: 3245
• Device Catalogue Number: 3245
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 05/19/2021; 06/04/2021; 06/29/2021; 08/17/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 06/07/2021; 06/09/2021; 07/06/2021; 08/17/2021
• 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: 79