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

Model Number 3688

Device Problem Detachment Of Device Component (1104)

Patient Problem Inadequate Pain Relief (2388)

Event Date 01/03/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr report number: 1627487-2014-10022.The patient (b)(6) received an scs system which included the ipg and one lead.It was reported the patient was no longer receiving effective therapy.The physician explanted the scs system and replaced it with a spinal modulation system.During the procedure, the physician observed that one of the port plugs for the explanted ipg was missing; however, he was unable to find it in the ipg pocket.The physician stated that he cannot be certain a port plug was placed during the original implant, but believes it was likely that there was.It was noted that there were no st.Jude representatives present for the procedure.Please note: add'l device info has been requested; however, no further info was available at the time of this report.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt's physician regarding medical history.

• Brand Name: EONC
• Type of Device: SCS IPG
• 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: karin bechler ; 6901 preston rd.; plano, TX 75024 ; 9723092511
• MDR Report Key: 3641888
• MDR Text Key: 4279893
• Report Number: 1627487-2014-10021
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2013
• Device Model Number: 3688
• Device Lot Number: 3286258
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2011
• 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