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

Model Number 3688

Device Problem Premature End-of-Life Indicator (1480)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/09/2014

Event Type  Injury  

Event Description

It was reported the pt's ipg has the low battery warning.The ipg was explanted and replaced.The pt's stimulation was restored following the surgery.

Manufacturer Narrative

The complaint of battery depletion was not confirmed.The ipg was received in good condition and communicated with lab equipment.The lab pt programmer initially displayed the low battery warning prior to decontamination; however, the low battery warning was not observed at the time of analysis.A pulse load test revealed the loaded battery voltage remained above the low battery threshold.Battery passivation could explain the low battery flag observed in the field and prior to analysis.Pre-decontamination communication with lab utilities and lab pt programmer could clear minimal passivation.Sjm has limited information 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; plano TX
• Manufacturer Contact: connie timmons ; 6901 preston rd.; plano, TX 75024 ; 9723098054
• MDR Report Key: 4252649
• MDR Text Key: 20066112
• Report Number: 1627487-2014-12746
• 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
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2014
• Device Model Number: 3688
• Device Lot Number: 3790459
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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: IMPLANT DATE:; SCS LEADS: MODEL 3186(2)
• Patient Outcome(s): Other
• Patient Age: 84 YR