MAUDE Adverse Event Report: ABBOTT MEDICAL PERMANENT IMPLANT LEAD KIT 50CM (AUS); DRG LEAD

Model Number MN20450-50AU

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  Injury  

Manufacturer Narrative

E1 reporter phone number: (b)(6).The unique device identifier (udi #) is unknown because the lot and part number were not provided.

Event Description

Manufacturer report number 1627487-2023-05223, 1627487-2023-05245, 1627487-2023-05246.It was reported during an elective explant surgery on (b)(6) 2023 the physician was unable to remove the entire leads due to ball tip of the drg leads being lodged in the neural foramen.Physician cut the leads and left the portion of leads implanted.

Manufacturer Narrative

During an elective explant surgery, the physician was unable to remove the entire leads due to ball tip of the drg leads being lodged in the neural foramen.Physician cut the leads and left the portion of leads implanted.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.

• Brand Name: PERMANENT IMPLANT LEAD KIT 50CM (AUS)
• 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: 18078664
• MDR Text Key: 327448319
• Report Number: 1627487-2023-05244
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MN20450-50AU
• Device Lot Number: AB0770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other