MAUDE Adverse Event Report: ST. JUDE MED - NEUROMODULATION RENEW RECEIVER; SCS RECEIVER

Model Number 3416

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 09/17/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report #1627487-2014-12711.It was reported the patient's system is not working correctly.The patient is pending a surgical consult with the surgeon.

Manufacturer Narrative

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.

• Brand Name: RENEW RECEIVER
• Type of Device: SCS RECEIVER
• Manufacturer (Section D): ST. JUDE MED - NEUROMODULATION; plano TX
• Manufacturer Contact: connie timmons ; 6901 preston rd.; plano, TX 75024 ; 9723098054
• MDR Report Key: 4212886
• MDR Text Key: 19724280
• Report Number: 1627487-2014-12710
• 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: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2004
• Device Model Number: 3416
• Device Lot Number: 156221B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2002
• 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: 74 YR