MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 90CM; DRG SLIM TIP LEAD

Model Number MN10450-90A

Device Problem Break (1069)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/05/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2021-13266.It was reported that the patient experienced ineffective stimulation.The lead is fractured and diagnostics revealed high impedances on multiple contacts.Reprogramming was unable to restore effective stimulation.In turn, surgical intervention may be pending to address the issue.

Event Description

Additional information received stated that the patient underwent surgical intervention on (b)(6) 2021 wherein the physician attempted to remove the leads, but was unable to as they were stuck.The physician decided to leave the leads implanted and close the site.Surgical intervention may take place at a later date to address the issue.

Event Description

Additional information received stated the patinet underwent surgical intervention on (b)(6) 2021 to explant the leads.The physician was unable to explant the entire lead and had to cut them and leave part of the leads attached to the flank.The physician implanted new leads and stimulation therapy was restored post-operatively.

Manufacturer Narrative

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, 90CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11683657
• MDR Text Key: 245982244
• Report Number: 1627487-2021-13265
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025548
• UDI-Public: 05415067025548
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/07/2021

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: 05/17/2019
• Device Model Number: MN10450-90A
• Device Catalogue Number: MN10450-90A
• Device Lot Number: AB2324
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2021
• Initial Date FDA Received: 04/19/2021
• Supplement Dates Manufacturer Received: 04/20/2021; 05/06/2021; 06/02/2021
• Supplement Dates FDA Received: 05/10/2021; 05/26/2021; 06/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG SLIM TIP LEAD; DRG SLIM TIP LEAD
• Patient Outcome(s): Other
• Patient Weight: 91