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

Model Number MN10450-50A

Device Problem Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/04/2024

Event Type  Injury  

Event Description

It was reported that patient experienced ineffective therapy due to lead migration.Surgical intervention is pending to address the issue.The investigation was unable to determine the lead that was associated with the issue.

Manufacturer Narrative

Date of event is estimated.Additional components potentially involved in the event include: common device name: drg: lead, model: mn10450-50a, udi: (b)(4), serial:(b)(6), batch: 10139508.

Manufacturer Narrative

It was reported to abbott, a patients s1 lead had migrated out of the sacral foramen.The patient underwent a revision.During removal of the migrated r s1 lead, the left lead retracted from the sacral foramen.Due to this complication, the physician explanted and replaced both leads.Effective therapy was restored.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

Event Description

Additional information received identified that patient underwent surgical intervention wherein, the leads were explanted and replaced.Effective therapy was restored post operatively.

• 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: 19169609
• MDR Text Key: 340897123
• Report Number: 1627487-2024-08329
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: (01)05415067027153(10)10139508(17)260107
• 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
• Report Date: 04/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MN10450-50A
• Device Lot Number: 10139508
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/08/2024
• 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 LEAD
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 98 KG