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

Model Number 3788

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/01/2011

Event Type  Injury  

Event Description

Information provided by the patient's attorney, indicated the patient alleges the following issues: the patient stated the scs ipg malfunctioned, was revised in (b)(6) of 2011 and explanted in (b)(6) of 2011.Additional information is needed to clarify the nature of the patient's issues.Sjm was made aware of the issues on (b)(6) 2014, and the patient's scs system was not evaluated by an sjm representative to verify and/or troubleshoot any of the reported issues prior to explant.

Event Description

Device 1 of 3 reference mfr.Reports: 1627487-2015-03103 & 1627487-2015-03104 additional historical information received from the medical chart review identified that prior to explant the patient also experienced pain at his scs lead site ((b)(6)2011) and pain and protruding at the scs anchor site after losing weight ((b)(6)2011).As a result, the patient underwent surgical intervention on (b)(6) 2011 during which the leads were "revised", scar tissue removed and "complex" programming was done.It was also reported the patient was hospitalized ((b)(6)2011) and received intra-venous antibiotics due to cellulitis and erythema at his scs lead incision(s) after initially receiving oral antibiotics for the erythema to no avail.Furthermore, on (b)(6)2011 an ultrasound confirmed fluid over the lead incision site.As a result, the scs system was explanted per infectious disease recommendation on (b)(6)2011 and the patient received antibiotics.The scs leads (same lot) and scs anchors (same lot) are being reported respectively as device 2 and device 3.Additional information is needed to clarify the nature of the patient's issues.Sjm was made aware of these issues on (b)(6)2015, and the patient's scs system was not evaluated by an sjm representative to verify and/or troubleshoot any of the reported issues prior to explant.

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.

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: EON MINI
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL ¿ NEUROMODULATION; plano TX
• Manufacturer Contact: rachel blackwell ; 6901 preston rd.; plano, TX 75024 ; 9725264637
• MDR Report Key: 4180053
• MDR Text Key: 5088417
• Report Number: 1627487-2014-03655
• 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: Other
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 03/02/2015

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: 01/01/2013
• Device Model Number: 3788
• Device Lot Number: 3301969
• Other Device ID Number: 05414734402651
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/02/2015
• Initial Date FDA Received: 10/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/27/2015
• 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
• Removal/Correction Number: 1627487-07262012-002-R
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS LEAD, MODEL: 3186 (2); IMPLANT DATE:; SCS ANCHOR, MODEL: 1192 (2)
• Patient Outcome(s): Other
• Patient Age: 53 YR