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

Model Number MN10450-50A

Device Problem Material Fragmentation (1261)

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

Event Date 06/09/2023

Event Type  Injury  

Event Description

It was reported that during a surgical intervention on (b)(6) 2023 (related manufacturer reference number: 1627487-2023-03074), the patient's left l1 lead fractured.The physician was unable to retrieve the fragment of the lead.As such, the fragment of the lead remains implanted.Investigation was unable to determine which of the leads fractured.

Manufacturer Narrative

Date of event is estimated.The allegation is against 1 of 2 leads; however, it is unknown which lead, therefore, all potential components are being listed.Additional components potentially involved in the event include: common device name: scs octrode lead, model: 3186, udi: (b)(4), serial: (b)(6), batch: 8562950.

Manufacturer Narrative

Date of event is estimated.Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.Additional components potentially involved in the event include: common device name: kit implantable slim tip lead, 50cm, model: mn10450-50a, udi: (b)(4), serial: (b)(6), batch: 8562950.

• 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: 17270147
• MDR Text Key: 318492714
• Report Number: 1627487-2023-03145
• Device Sequence Number: 1
• Product Code: PMP
• 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
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 8562950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2022
• 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; DRG LEAD (2)
• Patient Outcome(s): Other
• Patient Age: 37 YR
• Patient Sex: Female
• Patient Weight: 68 KG