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

Model Number MN10450-50A

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  Injury  

Manufacturer Narrative

A patient experienced lead migration was reported to abbott.The patient's right lead was explanted and replaced.Therapy was restored.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.

Event Description

Related manufacturer reference number: 1627487-2020-00477.It was reported that during the patient's revision procedure on (b)(6) 2020, the patient's right l1 lead had migrated.The lead was explanted and replaced.Note: since it is not known which device was causing the issue, all possible devices are being reported on.

• 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: 9593587
• MDR Text Key: 175178972
• Report Number: 1627487-2020-00476
• 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
• Report Date: 01/15/2020

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: 07/29/2020
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 6554210
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/10/2020
• Initial Date FDA Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2018
• 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 LEAD
• Patient Outcome(s): Other
• Patient Weight: 73