MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION CHARGING SYSTEM RECHARGEABLE IPG; SCS CHARGING SYSTEM

Model Number 3701

Device Problem Temperature Problem (3022)

Patient Problems Burning Sensation (2146); Discomfort (2330)

Event Date 12/11/2012

Event Type  Injury  

Event Description

Follow up information identified the patient reports the replacement charging system did not resolve the communication issue.The patient reports her scs system is not functioning.

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: 1627487-2014-22055 follow up information identified the scs system is not functioning and she is no longer receiving stimulation.The patient states she is unsure if she is using the charging system correctly and requests troubleshooting be performed by sjm representative.Further troubleshooting is pending at this time.

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: 1627487-2014-22055.The patient reports she experienced warmth while recharging her ipg.The warmth caused her discomfort and as a result she has not used her charging system in over two years.Communication between the programmer and ipg was unable to be verified.A replacement charging system (model 3726) was sent to the patient to verify communication with the ipg.On 08/01/2012 st.Jude medical, neuromodulation division, sent field action letters to patients related to heating while charging and raised awareness of this issue to patients.  an increase in prior non-reported heating while charging events and other non-reported events was expected.

Manufacturer Narrative

This charger model was associated with a field correction.Manufacturer's evaluation: corrective and preventive action (capa) investigation was performed.Evaluation: result: pocket heating was confirmed. the investigation for capa (b)(4) associated with heating while charging (pocket heating) concluded that the charger was capable of transferring energy to the ipg at a rate that would cause heating of the ipg and/or charging wand of sufficient elevated temperature to cause pain and burns. the heating while charging was determined to be exacerbated by off-axis charging of shallow implanted ipgs and that all chargers were capable of elevated heating.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: CHARGING SYSTEM RECHARGEABLE IPG
• Type of Device: SCS CHARGING SYSTEM
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; st. jude medical neuromodulation division; 6901 preston road; plano TX 75024 750
• MDR Report Key: 4371157
• MDR Text Key: 5170160
• Report Number: 1627487-2014-22054
• 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: Other
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/15/2015

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: 05/28/2015
• Device Model Number: 3701
• Device Lot Number: 3121047
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2015
• Initial Date FDA Received: 12/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/19/2015; 02/13/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/10/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: 1627487-07262012-001-C
• Patient Sequence Number: 1
• Treatment: MODEL 3149, SCS LEAD; MODEL 3341(2), SCS EXTENSION
• Patient Outcome(s): Other
• Patient Age: 63 YR