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

Model Number MN10450-50A

Device Problems Fracture (1260); Impedance Problem (2950)

Patient Problem Pain (1994)

Event Date 07/05/2020

Event Type  Injury  

Manufacturer Narrative

¿date of event¿ is estimated.Patient weight was not obtained due to patient declining to provide it.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-23688.It was reported that patient experienced pain in right groin/testacle area.Diagnostic testing revealed invalid impedance on multiple contacts of the right-side lead located at l1.Reprogramming did not resolve the issue.Surgical intervention occurred during which the lead was explanted and replaced to address the issue.It is unknown which lead is related to the issue so all suspected leads are being reported.

Manufacturer Narrative

Corrections: b5: the following should also have been entered in the initial report: "the lead was fractured." h6 - device code: "1260 - fracture" should have been entered rather than "2950 - impedance problem".

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.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 10389165
• MDR Text Key: 202345318
• Report Number: 1627487-2020-23687
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 09/08/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2021
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 7007986
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/10/2020
• Supplement Dates Manufacturer Received: 08/24/2020; 09/08/2020
• Supplement Dates FDA Received: 08/27/2020; 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG SLIM TIP LEAD; DRG SLIM TIP LEAD
• Patient Outcome(s): Other
• Patient Age: 32 YR