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

Model Number MN10450-50A

Device Problems Material Fragmentation (1261); Use of Device Problem (1670)

Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)

Event Date 11/08/2023

Event Type  Injury  

Manufacturer Narrative

Date of event estimated.The allegation is against 1 of 2 lead; however, it is unknown which lead(s), 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: 7011051.

Event Description

Related manufacturer reference number: 1627487-2023-05679.It was reported that during a surgical procedure a complication occurred where the patient's right s2 lead broke off and was partially left implanted, as well as the right l5 lead broke off and was left partially implanted.The surgery was extended by 70 minutes.Effective stimulation was restored, but 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.The allegation is against 1 of 2 leads; however, it is unknown which lead(s), 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: 7011051.

Manufacturer Narrative

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.

Manufacturer Narrative

Correction - codes.

Manufacturer Narrative

Date of event estimated.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: 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: 18242571
• MDR Text Key: 329428739
• Report Number: 1627487-2023-05678
• 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,Followup,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2021
• Device Model Number: MN10450-50A
• Device Lot Number: 7011051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/06/2019
• 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: Female
• Patient Weight: 54 KG