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

Model Number	3244
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	11/03/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is estimated.Attempts were made to obtain complete event information.Additional information was not provided.The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
It was reported that the patient is experiencing ineffective therapy due to high impedances on all contacts on the scs paddle lead.In turn, the patient may undergo surgical intervention to address the issue.
Additional Manufacturer Narrative
It was reported to abbott; a rep met with a patient and observed high impedance on all the lead¿s contacts.The issue was resolved with surgical intervention.The existing lead and extension were explanted and replaced.The lead was fractured.The ipg was also replaced and repositioned due to the large size and uncomfortable location of the ipg.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.
Event or Problem Description
It was reported that the patient underwent surgical intervention wherein the scs system was explanted and replaced to address the issue.

• Brand Name: LAMITRODE 44 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10864322
• Report Number: 1627487-2020-47983
• Device Sequence Number: 2635563
• Product Code: LGW
• UDI-Device Identifier: 05414734406215
• UDI-Public: 05414734406215
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/23/2020

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: 11/08/2019
• Device Model Number: 3244
• Device Catalogue Number: 3244
• Device Lot Number: 6189170
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 11/20/2020; 12/17/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/07/2020; 12/23/2020
• 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: 82