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

Model Number 3186

Device Problem Material Fragmentation (1261)

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

Event Date 03/19/2021

Event Type  Injury  

Event Description

Device 1 of 2 reference mfr.Report#: 3006705815-2021-01540.It was reported the patient underwent surgical intervention for an issue reported under mfr.Report#: 3006705815-2021-01403 and 3006705815-2021-01404.During the procedure, one of the patient's leads was successfully explanted.Upon removal of the patient's other lead, the doctor unintentionally cut it.The doctor was unable to fully remove the cut lead, so the doctor decided to leave the cut lead inside the patient.In turn, the doctor decided to implant two new leads to complete the procedure.Note: both of the patient's leads are being reported because it's unknown which lead was unintentionally cut/partially remaining implanted.

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 2.Reference mfr.Report#: 3006705815-2021-01540.

• 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: 11611171
• MDR Text Key: 243677789
• Report Number: 3006705815-2021-01539
• 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
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/18/2021
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000086684
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: 3186.; MODEL: 3186
• Patient Outcome(s): Other
• Patient Weight: 86