MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG LEAD

Model Number MN10450-50A

Device Problem Disconnection (1171)

Patient Problems Pain (1994); Inadequate Pain Relief (2388)

Event Date 04/21/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.The results/method and conclusion codes along with investigation results will be provided in the final report.During processing of this complaint, attempts were made to obtain patient weight, but it could not be obtained.

Event Description

Related manufacturer reference numbers: 1627487-2020-04540; 1627487-2020-04541.It was reported that the patient lost stimulation and experienced pain.X-ray imaging confirmed that the leads pulled out of the ipg header and a lead may be rubbing against a nerve.A steroid injection was administered, but the issue was not resolved.As a result, surgery may occur to address the issue.

Manufacturer Narrative

Correction: date of explant should have been included in the previous report.

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.

Event Description

Additional reporting was received that surgery occurred in which the leads were explanted and replaced, which resolved the issue.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10050271
• MDR Text Key: 190741482
• Report Number: 1627487-2020-04539
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• 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: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/17/2020

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: 01/12/2022
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 7333916
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 05/13/2020
• Supplement Dates Manufacturer Received: 06/04/2020; 06/17/2020
• Supplement Dates FDA Received: 06/15/2020; 06/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/13/2020
• 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
• Patient Outcome(s): Other