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

Model Number MN10450-50A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Inadequate Pain Relief (2388)

Event Type  Injury  

Manufacturer Narrative

Therapy date is estimated.

Event Description

Product manufacturer reference number: 1627487-2019-10882, and 1627487-2019-10884.It was reported that the patient did not have adequate therapy.Diagnostics revealed lead migration confirmed with x-ray.As a result, surgical intervention took place on (b)(6) 2019, but the physician could not implant new leads due to scar tissue and the procedure was abandoned.No leads were implanted or explanted.

• Brand Name: 50CM IMPLANT LEAD KIT, SLIM TIP
• 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: 9121008
• MDR Text Key: 160097722
• Report Number: 1627487-2019-10885
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/30/2019

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: 12/14/2018
• Device Model Number: MN10450-50A
• Device Lot Number: AB2230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 09/25/2019
• Supplement Dates Manufacturer Received: 09/26/2019
• Supplement Dates FDA Received: 09/30/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2016
• 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: MODEL MN10450-50A DRG LEAD (X2)
• Patient Outcome(s): Other