MAUDE Adverse Event Report: ST. JUDE MEDICAL ¿ NEUROMODULATION PENTA; SCS LEAD

Model Number 3228

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 06/20/2014

Event Type  Injury  

Event Description

Device 1 of 2.Ref mfr report: 1627487-2014-06198.Info received identified the pt experienced warmth at the ipg site while recharging and the device would shock her every time she used it.Pt has pain at the implant site and over leads.The pt is requesting to have her scs system removed.Surgical intervention may be pending to address the issue.On 08/01/2012 st.Jude medical, neuromodulation division, sent field action letters to pts related to heating while charging and raised awareness of this issue to pts.An increase in prior non-reported heating while charging events and other non-reported events was expected.

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.

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-06198.

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.

Event Description

Device 1 of 2.Reference mfr report: 1627487-2014-06198.Further investigation identified the patient was recently implanted with a pacemaker.Per the patient, she did not have any problems with her scs system prior to the pacemaker being implanted.The patient turned stimulation off due to the shocking issue, declined reprogramming and the scs system was explanted.

Event Description

Device 1 of 2; reference mfr report: 1627487-2014-06198.

• Brand Name: PENTA
• Type of Device: SCS LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL ¿ NEUROMODULATION; plano TX
• Manufacturer Contact: kimberly goode ; 6901 preston road; plano, TX 75024 ; 9723098541
• MDR Report Key: 3976360
• MDR Text Key: 4751797
• Report Number: 1627487-2014-06197
• 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,company representative,oth
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2014
• Device Model Number: 3228
• Device Lot Number: 3872102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS ANCHOR, MODEL 1194 (2)
• Patient Outcome(s): Other
• Patient Age: 53 YR