MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PRODIGY; SCS IPG

Model Number 3799

Device Problems Disconnection (1171); Difficult to Insert (1316)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report: 1627487-2014-21585.The patient (b)(6) is enrolled in a clinical study.It was reported during post-operative programming, diagnostics indicated a "connection" issue.As a result, the patient underwent surgical intervention on (b)(6) 2014 and it was noted the lead was not fully inserted into the ipg header.The ipg/lead connection was restored as a result of the procedure.It was reported the physician experienced difficulty inserting the lead into the header at the implant procedure.

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: PRODIGY
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: palka sharma ; 6901 preston rd.; plano, TX 75024 ; 9725264823
• MDR Report Key: 4093585
• MDR Text Key: 17994249
• Report Number: 1627487-2014-21584
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 08/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2015
• Device Model Number: 3799
• Device Lot Number: 4242446
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2013
• 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: 42 YR
• Patient Weight: 98