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

Model Number 3186

Device Problems Use of Device Problem (1670); Material Split, Cut or Torn (4008)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Device 1 of 2.Reference mfr.Report#: 3006705815-2020-02588.It was reported the patient underwent surgical intervention for an issue reported under mfr report#: 3006705815-2020-02583 and 3006705815-2020-02584.During surgical intervention, one of the patient's leads was cut accidentally by the physician when they attempted to relocate both of the patient's leads.In turn, the physician decided to remove the portion of the lead that was cut and left the remaining portion of the lead in the patient.Both of the patient's leads are being reported because it's unknown which lead was cut by the physician.

Event Description

Device 1 of 2 reference mfr.Report#: 3006705815-2020-02588.

Manufacturer Narrative

Corrected data: h6 - device code.The event information pertaining to this incident has been reviewed and no product investigation can be performed as there are no complaint allegations present nor were the circumstances of the event attributed to the implanted system.

Event Description

Additional information received indicates the partial lead was explanted.

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: 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: 10215083
• MDR Text Key: 197096840
• Report Number: 3006705815-2020-02587
• 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,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2021
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000075577
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: 3186, SCS LEAD
• Patient Outcome(s): Other
• Patient Weight: 86