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 Hemorrhage/Bleeding (1888)

Event Date 05/09/2018

Event Type  Injury  

Manufacturer Narrative

The manufacturer has limited information related to the patient's medical history and is unable to form an opinion as to the relevancy of the patient's history to the event reported.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 2 of 2.Reference mfr.Report#: 3006705815-2018-01311.It was reported the patient underwent a permanent, scs implant procedure.During the procedure, the patient began to bleed excessively.As a result, the procedure was abandoned.The patient might be sent for labs to determine why his blood wasn't clotting regularly.

Event Description

Device 2 of 2: reference mfr.Report#: 3006705815-2018-01311.Follow-up revealed the patient is doing well.

Manufacturer Narrative

Corrected data: date received by manufacturer (upon further review, it was determined the awareness date listed on the previous follow-up report was incorrect.The correct date was (b)(6) 2018.).

Event Description

Device 2 of 2 : reference mfr.Report#: 3006705815-2018-01311.

• 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
• 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: drew johnson ; 6901 preston road; plano, TX 75024 ; 9725264667
• MDR Report Key: 7562891
• MDR Text Key: 109880428
• Report Number: 3006705815-2018-01312
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/29/2018

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: 03/04/2020
• Device Model Number: 3186
• Device Lot Number: A000052983
• Other Device ID Number: 05415067017246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/01/2018
• Supplement Dates Manufacturer Received: 06/27/2018; 10/09/2018
• Supplement Dates FDA Received: 07/18/2018; 10/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2018
• 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
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Weight: 100