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

Model Number MN10450-50A

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/10/2024

Event Type  Injury  

Event Description

It was reported that the patient was receiving inadequate pain coverage from their drg system.Surgical intervention was undertaken on (b)(6) 2024 wherein 2 additional leads were added to the patient's system.Therapy was restored post operatively.

Manufacturer Narrative

Section b3: event date is estimated.The allegation is against one of two leads; however, it is unknown which leads, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: slim tip lead, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 9061760 it was reported to abbott, a patient underwent an lead revision.Surgery took place where two new leads were added to the existing drg system.There were no complications.Effective therapy was restored.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, the cause of the reported issue was determined not to be product related.

• 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: 19005789
• MDR Text Key: 338935992
• Report Number: 1627487-2024-07837
• 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
• Report Date: 03/29/2024

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?: No
• Device Operator: Health Professional
• Device Model Number: MN10450-50A
• Device Lot Number: 9022649
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2023
• 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 (X1); DRG LEAD (X1)
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 86 KG