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

Model Number MN10450-50A

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/29/2019

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

(reference regulatory number:1627487-2019-10283); (reference regulatory number:1627487-2019-10284); (reference regulatory number:1627487-2019-10285).It was reported the patient experienced uncomfortable stimulation due to lead migration.In turn, surgical intervention was undertaken wherein the right and left l2 and left l1 leads were explanted and replaced on (b)(6) 2019.Effective therapy was established post op.

Manufacturer Narrative

(b)(4).

• Brand Name: IMPLANT LEAD KIT, SLIMTIP, 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: 9084044
• MDR Text Key: 159075043
• Report Number: 1627487-2019-10286
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067025531
• UDI-Public: 05415067025531
• 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: 09/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/15/2018
• Device Model Number: MN10450-50A
• Device Lot Number: AB2212
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2016
• 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 (X3)
• Patient Outcome(s): Other
• Patient Weight: 73