MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PROCLAIM 7 ELITE; SCS LEAD

Model Number 3662

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

Patient Problems Fall (1848); Head Injury (1879); Hemorrhage/Bleeding (1888)

Event Date 12/02/2017

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 3, mfr report # 3006705815-2018-00022, 3006705815-2018-00023 it was reported the patient suffered a fall causing both incision sites to bleed.Reportedly, the patient presented to the er due to hitting her head and losing consciousness.Follow-up revealed the bleeding issue resolved.Surgical intervention was undertaken on (b)(6) 2017 wherein the entire scs system was explanted.Subsequently, the patient regained consciousness.

• Brand Name: PROCLAIM 7 ELITE
• Type of Device: SCS LEAD
• 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
• Manufacturer Contact: mahzad habibi ; 6901 preston road; plano, TX 75024 ; 9723098547
• MDR Report Key: 7172468
• MDR Text Key: 96654863
• Report Number: 1627487-2018-00098
• 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
• Report Date: 01/08/2018

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: 06/05/2019
• Device Model Number: 3662
• Device Lot Number: 6001237
• Other Device ID Number: 05415067020222
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/05/2017
• 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
• Treatment: MODEL: 1192 SCS, ANCHORS (2); MODEL: 3186 SCS, LEAD (2)
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 46 YR