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

Model Number	3288
Medical Device Problem Codes	Disconnection (1171); Migration (4003)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	10/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Related manufacturer reference number: 1627487-2022-06898.It was reported that x-rays showed disconnection between the lead and ipg.As such, the patient experienced ineffective therapy.A message was received stating the is an open circuit/high impedances.However, impedance check revelated that the impedance is in normal range.Surgical intervention may take place at a later date to address the issue.
Additional Manufacturer Narrative
Date of event is estimated.Reporter phone number: (b)(6).
Event or Problem Description
Additional information received indicates that surgical intervention took place on 06dec2022 wherein it was noted that the lead had migrated.As such, the lead was repositioned to correct location and extensions were added to the system to address the issue.Reportedly, the issue was resolved, and therapy was confirmed post op.
Event or Problem Description
Additional information received indicates that the distal ends of the leads that were disconnected were reinserted to the ipg.Nothing was done to the ipg, it was placed into the original pocket site.
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 88 LEAD KIT, 60CM LENGTH
• Common Device Name: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16001459
• Report Number: 1627487-2022-06923
• Device Sequence Number: 6679136
• Product Code: LGW
• UDI-Device Identifier: 05414734402248
• UDI-Public: 05414734402248
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P010032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/18/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/23/2022
• Device Model Number: 3288
• Device Catalogue Number: 3288
• Device Lot Number: 7708300
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2022
• Supplement Date Received by Manufacturer: 12/06/2022; 12/06/2022; 01/09/2023; 01/09/2023
• Initial Report FDA Received Date: 12/18/2022
• Supplement Report FDA Received Date: 12/29/2022; 01/01/2023; 01/17/2023; 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown