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

Model Number 3186

Device Problem Fracture (1260)

Patient Problem Inadequate Pain Relief (2388)

Event Date 08/27/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.

Event Description

Reference manufacturer report number: 3006705815-2021-04583.It was reported that the patient experienced ineffective therapy after falling through a wall.An x-ray was taken of the scs leads which confirmed a fracture on one of the leads.In turn, the patient underwent surgical intervention wherein the scs lead was explanted and replaced to address the issue.Since it is not known which device contributed to the issue, all possible devices are being reported on.

Manufacturer Narrative

A patient experiencing a lead fracture during an ipg revision was reported to abbott.The patient leads were explanted and replaced.Therapy was restored.The results of the investigation are inconclusive since the devices were not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.

• Brand Name: OCTRODE LEAD KIT, 60CM LENGTH
• Type of Device: PERCUTANEOUS 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: 12474945
• MDR Text Key: 271491743
• Report Number: 3006705815-2021-04582
• 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: 09/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/15/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000092200
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3816, SCS LEAD; MODEL 3816, SCS LEAD
• Patient Outcome(s): Other
• Patient Weight: 75