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

Model Number 3186

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 03/05/2021

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.Attempts were made to obtain complete event and patient information.Additional information was not provided.

Event Description

Reference manufacturer number: 1627487-2021-02349.It was reported that the patient experienced ineffective therapy due to impedance issues on their scs lead.X-rays confirmed that the patient's scs lead had pulled out from the scs extension.The patient stated that they experienced physical trauma around the time when they lost therapy.In turn, the patient underwent surgical intervention on (b)(6) 2021 wherein the scs lead and extension were explanted and replaced to address the issue.Since it is not known which device contributed to the issue, all possible devices are being reported.

Manufacturer Narrative

The reported event of invalid impedance/ineffective stimulation was visually confirmed.As received, microscopic inspection revealed that the lead body had kink/breakage with all wires broken in it.The broken wires are consistent with overstress condition that the lead was subjected while in vivo.

• 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: 11556591
• MDR Text Key: 241872492
• Report Number: 3006705815-2021-01352
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000101932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/23/2021
• Supplement Dates Manufacturer Received: 04/08/2021
• Supplement Dates FDA Received: 04/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3383, SCS EXTENSION; MODEL 3383, SCS EXTENSION
• Patient Outcome(s): Other