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

Model Number 3186

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

Patient Problem Irritation (1941)

Event Date 07/17/2020

Event Type  Injury  

Manufacturer Narrative

Date of event is estimated.During processing of this complaint, an attempt was made to obtain complete event and patient information.The results/method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

Device 1 of 3.Reference mfr.Report#: 3006705815-2020-30544.Reference mfr.Report#: 1627487-2020-23621.It was reported the patient has developed sores all over their body.As a result, surgical intervention is pending.

Manufacturer Narrative

Patient's weight was obtained via follow-up and has been provided.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 event could not be conclusively determined.

Event Description

Device 1 of 3 reference mfr.Report#: 3006705815-2020-30544 reference mfr.Report#: 1627487-2020-23621 follow-up revealed the patient's scs system was explanted.

• 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: 10365663
• MDR Text Key: 201664193
• Report Number: 3006705815-2020-30543
• 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: 09/11/2020

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: 05/15/2019
• Device Model Number: 3186
• Device Catalogue Number: 3186
• Device Lot Number: A000040378
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/04/2020
• Supplement Dates Manufacturer Received: 09/09/2020
• Supplement Dates FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL: 3186; MODEL: 3660; MODEL: 3186; MODEL: 3660
• Patient Outcome(s): Other
• Patient Weight: 57