MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE 88 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number	3288
Medical Device Problem Code	High impedance (1291)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date is an estimate.
Event or Problem Description
It was reported that the patient's implanted lead has high impedances.As result, the patient may undergo surgical intervention on a later date.
Event or Problem Description
Related manufacture number: 3006705815-2021-02844.Additional information received indicates that the patient's entire system was explanted and replaced.Effective therapy was established post-operative.
Additional Manufacturer Narrative
Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: LAMITRODE 88 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11829404
• Report Number: 1627487-2021-14023
• Device Sequence Number: 4414306
• Product Code: LGW
• UDI-Device Identifier: 05414734406307
• UDI-Public: 05414734406307
• 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: 2015
• 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): 06/28/2021

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: 05/28/2016
• Device Model Number: 3288
• Device Catalogue Number: 3288
• Device Lot Number: 4606680
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/26/2021
• Supplement Date Received by Manufacturer: 05/21/2021; 06/22/2021
• Initial Report FDA Received Date: 05/14/2021
• Supplement Report FDA Received Date: 06/10/2021; 06/28/2021
• 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 IPG, MODEL 3772
• Outcome Attributed to Adverse Event: Other
• Patient Weight: 73