MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) OCTRODE LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3186

Device Problem Low impedance (2285)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2021

Event Type  Injury  

Manufacturer Narrative

The patient's weight is unknown.

Event Description

Device 1 of 3.Reference mfr.Report#: 3006705815-2021-01832.Reference mfr.Report#: 3006705815-2021-01833.It was reported the patient has been unable to set their ipg into mri mode due to low impedance being present.Troubleshooting attempts were performed but were unable to provide resolution.As a result, the patient plans to undergo surgical intervention.

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

Device 1 of 3: reference mfr.Report#: 3006705815-2021-01832.Reference mfr.Report#: 3006705815-2021-01833.

Manufacturer Narrative

A4 - patient weight was obtained via follow-up.

Event Description

Device 1 of 3 reference mfr.Report#: 3006705815-2021-01832.Reference mfr.Report#: 3006705815-2021-01833.Additional information obtained via follow-up revealed the patient's scs system was explanted.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 11688534
• MDR Text Key: 246218642
• Report Number: 3006705815-2021-01831
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2020
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000051716
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: 3186; MODEL: 3772
• Patient Outcome(s): Other
• Patient Weight: 82