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

Model Number 3186

Device Problems Difficult to Remove (1528); Separation Failure (2547)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/14/2021

Event Type  Injury  

Event Description

Related manufacturer reference number: 3006705815-2021-06043.It was reported during the patients ipg procedure the leads were unable to be removed from the ipg.As a result, the physician cut the leads.The cut leads remain implanted.Additional surgical intervention may take place at a later date.

Event Description

It was reported surgical intervention was undertaken wherein the leads were explanted and replaced.

Manufacturer Narrative

The report of ¿electrodes could not be removed from the ipg header¿ was confirmed.Analysis of the returned ipg found that the header was disassembled / torn apart during explant procedure due to ¿stuck leads¿.Analysis of the returned terminal end lead segments found the ipg setscrew had been torqued all the way down until the contact of the lead was flattened out in the connector block.Once the contact of the lead was flattened out and distorted, the lead was not able to be removed.The pattern of the setscrew engagement marks is consistent with improper use of the supplied torque wrench, or using a different wrench than the one supplied.

• 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
• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 12912421
• MDR Text Key: 281579865
• Report Number: 3006705815-2021-06042
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017246
• UDI-Public: 05415067017246
• 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,Followup
• Report Date: 02/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/21/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000092555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/15/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/13/2021; 02/17/2022
• Supplement Dates FDA Received: 12/29/2021; 02/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2020
• 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
• Treatment: SCS IPG
• Patient Outcome(s): Other