MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LEAD DELIVERY SYS, 13 CM (5 IN), 1 EACH; SCS LEAD DEVLIVERY SYSTEM

Model Number 1772

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/08/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Sjm 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.Sjm defers to the patient¿s physician regarding medical history.(b)(4).

Event Description

It was reported the patient had a trial procedure on (b)(6) 2015.During the procedure, the patient experienced excessive bleeding after the physician inserted epidural needle into the patient's epidural space.The patient had been taking aspirin which may be contributing to the bleeding.As a result, the doctor decided to abandon the procedure.

• Brand Name: LEAD DELIVERY SYS, 13 CM (5 IN), 1 EACH
• Type of Device: SCS LEAD DEVLIVERY SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 5196245
• MDR Text Key: 30202674
• Report Number: 1627487-2015-07624
• Device Sequence Number: 1
• Product Code: LHG
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/08/2015

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: 01/31/2017
• Device Model Number: 1772
• Device Lot Number: 5006851
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 11/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2015
• 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: 53 YR