MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3788

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

Patient Problems Unspecified Infection (1930); Ulceration (2116)

Event Date 12/19/2014

Event Type  Injury  

Event Description

Device 1 of 2.Reference mfr.Report: 1627487-2015-21012.It was reported the patient's (b)(6) ipg would not communicate with two different programmers.The patient alleges charging the ipg approximately 3-4 weeks ago.While troubleshooting the issue in the clinic, an ulceration was noted at the upper border of the ipg site.Per the physician, the ipg site was infected.Subsequently, the ipg and extensions were explanted and replaced.A new ipg was implanted in the abdomen.The physician left the leads implanted, however, the leads were cut to facilitate the explant process.New leads will be implanted at a later date.The implant date for the following product is unknown: model 3156(4), scs lead.

Manufacturer Narrative

Correction number: 1627487-12192011-003-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.

Manufacturer Narrative

Results: the complaint for no communication was confirmed.As returned, the ipg would not communicate due to a depleted battery.The battery was recovered and the ipg communicated, charged, and was tested to manufacturing specifications using the autotester.The autotest failed ucod due to no output on channel 8 and 16.Visual inspection revealed a broken feed through wire on channel 8 and 16.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.

Manufacturer Narrative

Analysis for infection was inadvertently omitted from follow-up 002.This information is being added below.Results: complaint for discomfort at the ipg site due to infection cannot be confirmed through product analysis testing.

Event Description

Device 1 of 2.Reference mfr.Report: 1627487-2015-21012.Follow-up identified the patient's infection has resolved.

Manufacturer Narrative

Evaluation: method: the device history and sterilization records were reviewed.Results: the device history and sterilization records reviewed were found to meet specifications and no anomalies related to this event were found.Conclusion: the cause of the reported complaint could not be determined from the review of the dhr and sterilization records.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 IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano, tx
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 4405147
• MDR Text Key: 5126894
• Report Number: 1627487-2015-21011
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2012
• Device Model Number: 3788
• Device Lot Number: 3224696
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 01/09/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/05/2015; 03/23/2015; 04/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Patient Outcome(s): Other