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 03/19/2024

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Initial reporter phone number: (b)(6).

Event Description

It was reported that the patient was unable to set their ipg to mri mode due to low impedances on both leads.It was noted that the patient had a fall prior and impedances would change depending on patient movement.As a result, the patient underwent surgical intervention during which the leads were explanted and replaced.Effective therapy was established post-operatively.

Manufacturer Narrative

The allegation of potentially fractured leads was not confirmed.Both leads show normal impedances.Both leads have no visual anomalies in the lead body, stim ends or terminal ends.Setscrew marks were seen on the terminal block electrodes at the terminal end.The event remains unknown.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19057121
• MDR Text Key: 339549096
• Report Number: 3006705815-2024-02599
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: (01)05415067017246(10)A000145331(17)250802
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3186
• Device Lot Number: A000145331
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• 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
• Patient Outcome(s): Other