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

Model Number MN10450-50A

Device Problem Material Fragmentation (1261)

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

Event Date 12/06/2022

Event Type  Injury  

Event Description

It was reported that during a lead revision a lead was stuck in the ipg header, when removing the lead from the epidural space the lead kinked and the contacts were sheared off in the epidural space.Surgical intervention took place where the leads were explanted and replaced.Fragments were unretrievable and remain in the epidural space.Surgical intervention may take place at a future date to address the issue.Investigation was unable to determine which of the lead attributed to the event.

Manufacturer Narrative

Date of event estimated.During processing of this incident, attempts were made to obtain complete patient information.Further information was requested but not received.Additional components potentially involved in the event include: common device name: lead, model: mn10450-50a, udi: (b)(4), serial: (b)(4), batch: 7278915.

Manufacturer Narrative

It was reported that during a lead revision a lead was stuck in the ipg header, when removing the lead from the epidural space the lead kinked and the contacts were sheared off in the epidural space.Surgical intervention took place where the leads were explanted and replaced.Fragments were unretrievable and remain in the epidural space.Surgical intervention may take place at a future date to address the issue.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG SLIM TIP 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 16036203
• MDR Text Key: 306018153
• Report Number: 1627487-2022-07008
• 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: 03/09/2023

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: 11/17/2021
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 7278915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2019
• 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 LEAD (X2)
• Patient Outcome(s): Other
• Patient Sex: Female