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

Model Number MN20450-50A

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/18/2023

Event Type  Injury  

Manufacturer Narrative

E1 reporter phone number: (b)(6).

Event Description

It was reported that during a lead revision procedure on (b)(6), 2023 (related manufacturer reference number: 1627487-2024-00102) the lead could not be completely removed.Hence, a portion of the lead remains implanted.There is no intervention planned to remove the lead at this time.

Manufacturer Narrative

It was reported to abbott, a patient underwent a lead revision to address high impedance.During the revision a lead fragment was left 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.A dhr review showed that part # (b)(6) (50cm slimtip implant lead kit, eu, abt serial # (b)(6) ,batch 8138076 and model mn20450-50a had been manufactured, tested, packaged, and sterilized according to the current manufacturing specifications and passed all manufacturing test, visual inspection, and sterilization requirements.

• 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: 18454520
• MDR Text Key: 332197523
• Report Number: 1627487-2024-00121
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/24/2024

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
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: MN20450-50A
• Device Lot Number: 8138076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/18/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 05/06/2024
• Supplement Dates FDA Received: 05/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• 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
• Patient Outcome(s): Other