MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG LEAD

Model Number MN10450-50A

Device Problems High impedance (1291); Migration (4003)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2023

Event Type  Injury  

Manufacturer Narrative

Date of event estimated.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.The allegation is against 1 of 4 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 7610202.Common device name: lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 7610202.Common device name: lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 7610202.

Event Description

It was reported that the patient wasn't able to get into mri mode, upon further investigation system diagnostics recorded high impedances on the left l1 lead.Surgical intervention may take place at a future date to address the issue.Investigation was unable to determine which of the leads attributed to the event.

Manufacturer Narrative

Date of event estimated.

Event Description

Additional information was received stating that leads had migrated, which was confirmed via imaging.Surgical intervention took place where the leads were explanted and replaced to address the issue.Effective stimulation was restored.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG 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: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19006432
• MDR Text Key: 338981552
• Report Number: 1627487-2024-07819
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2022
• Device Model Number: MN10450-50A
• Device Lot Number: 7610202
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: DRG IPG; DRG LEADS (X3)
• Patient Outcome(s): Other
• Patient Age: 45 YR
• Patient Sex: Male
• Patient Weight: 104 KG