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

Model Number MN10450-90A

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problem Undesired Nerve Stimulation (1980)

Event Date 09/10/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Related manufacturer reference number: 1627487-2022-00566.It was reported the patient feels uncomfortable stimulation between the shoulder blades.Reprogramming was unable to resolve the issue.Surgical intervention may be pending to address the issue.

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 event could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device, patient and event information.

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 event could not be conclusively determined.During processing of this complaint, attempts were made to obtain complete device and event information.

Event Description

Additional information was received indicating the pain was caused by lead migration.As a result, surgical intervention was undertaken wherein the leads were explanted and replaced to resolve the issue.

• 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
• 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: 13401583
• MDR Text Key: 284815477
• Report Number: 1627487-2022-00567
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027160
• UDI-Public: 05415067027160
• 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
• Report Date: 06/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/19/2021
• Device Model Number: MN10450-90A
• Device Catalogue Number: MN10450-90A
• Device Lot Number: 7034984
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2019
• 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
• Patient Outcome(s): Other
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 113 KG