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

Model Number MN20450-50A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Unique device identifier (udi #): the udi is unknown because the serial number and/or lot number were not provided.The results/method and conclusion codes along with investigation results will be provided on the final report.During the processing of this incident attempts were made to obtain complete device information.

Event Description

Related manufacturer reference number: 1627487-2020-31995.It was reported that patient experienced ineffective stimulation due to lead migration issue which was confirmed via x-ray.The system was explanted (on an unknown date) and replaced with one from a different manufacturer.

Manufacturer Narrative

The results of the investigation are inconclusive, and the root cause of the reported incident is unknown as the device was not returned for analysis.

• 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10792884
• MDR Text Key: 214808679
• Report Number: 1627487-2020-33345
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MN20450-50A
• Device Catalogue Number: MN20450-50A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Patient Outcome(s): Other