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

Model Number 3788

Device Problem Delayed Charge Time (2586)

Patient Problems Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)

Event Date 06/17/2014

Event Type  Injury  

Event Description

Device 1 of 3 reference mfr report: 1627487-2014-26650 and 26651.The patient reported she was lodged between a mechanical device and a counter and her ipg that is implanted in her hip was lodged onto the counter.Since the event, she is only able to feel the stimulation when she points her head upwards.After the incident, she is experiencing increased recharge burden.Follow up information identified that when she reaches her arms in front of her, the stimulation increases dramatically.The patient is also receiving sporadic jolts 4-5 times a day and is not associated with any particular movement or anomalies.Lead diagnostics revealed impedances within normal range.The patient underwent surgical intervention to remove and replace her ipg.The patient had effective stimulation postoperatively.

Manufacturer Narrative

Field correction: 1627487-05242011-002-r.This ipg serial number was included in field advisories.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: EON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: tanja hoffman ; 6901 preston rd.; plano, TX 75024 ; 9723098520
• MDR Report Key: 4023350
• MDR Text Key: 19767196
• Report Number: 1627487-2014-26645
• 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: Consumer
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 07/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2010
• Device Model Number: 3788
• Device Lot Number: 172704
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2014
• Date Manufacturer Received: 07/25/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/01/2008
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-12192011-003-R
• Patient Sequence Number: 1
• Treatment: IMPLANT:; SCS ANCHOR: MODEL 1194
• Patient Age: 53 YR