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

Model Number 3186

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Rash (2033)

Event Type  Injury  

Manufacturer Narrative

Event date is unknown.

Event Description

Related manufacturer reference number: 3006705815-2021-02542, 3006705815-2021-02544, 1627487-2021-14276, and 1627487-2021-14277.It was reported that the patient was experiencing a rash and irritation along most their back.The patient had a wound washout on (b)(6) 2021.No infection was confirmed.Patient was placed on antibiotics as a precaution.As a result the whole system was explanted on (b)(6) 2021.

Manufacturer Narrative

The case of wound wash out was reported to abbott.The patient had a wound washout due to experiencing a rash and irritation along most their back.No infection was confirmed.Patient was placed on antibiotics as a precaution.As a result the whole system was explanted.No implanted devices were returned for evaluation.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.

• 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: 11868723
• MDR Text Key: 252163713
• Report Number: 3006705815-2021-02543
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 05/31/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2022
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000094658
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/11/2021
• Initial Date FDA Received: 05/23/2021
• Supplement Dates Manufacturer Received: 05/24/2021
• Supplement Dates FDA Received: 05/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PERCUTANEOUS LEAD; SCS ANCHOR (X2); SCS IPG
• Patient Outcome(s): Other
• Patient Weight: 91