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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLETOTALLY IMPLANTABLE PULSE GENERATOR

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ST. JUDE MEDICAL - NEUROMODULATION EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR   Back to Search Results
Model Number 3788
Device Problems Failure to charge; Telemetry discrepancy; Communication or transmission issue
Event Date 08/16/2011
Event Type  Injury   Patient Outcome  Required Intervention
Event Description

The patient received her scs system on (b)(6) 2009. It was reported the patient lost stimulation and was unable to communicate with the charger or programmer. The ipg was replaced on (b)(6) 2011. No further complications were reported.

 
Manufacturer Narrative

This ipg serial number was included in a field advisory. Evaluation: results - the complaints were confirmed. As returned, the ipg would not communicate due to a depleted battery and therefore could not provide stimulation. The battery was recovered and the ipg communicated, charged, was tested to manufacturing specifications using the autotester. The ipg passed all tests on the autotester. 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.

 
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Brand NameEON MINI IPG, 16-CHANNEL RECHARGEABLE
Type of DeviceTOTALLY IMPLANTABLE PULSE GENERATOR
Manufacturer (Section F)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer (Section D)
ST. JUDE MEDICAL - NEUROMODULATION
plano TX
Manufacturer (Section G)
Manufacturer Contact
jennifer clair
6901 preston rd.
plano , TX 75024
(972) 526 -4677
Device Event Key2289444
MDR Report Key2269280
Event Key2166175
Report Number1627487-2011-04257
Device Sequence Number1
Product CodeLGW
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation NOT APPLICABLE
Remedial Action Recall
Type of Report Initial
Report Date 08/31/2011
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/27/2011
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/01/2011
Device MODEL Number3788
Device LOT Number2864606
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer09/06/2011
Is The Reporter A Health Professional? No
Event Location AMBULATORY SURGICAL Facility
Was The Report Sent To Manufacturer? No
Date Manufacturer Received08/30/2011
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/01/2009
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Initial
Removal/Correction Number1627487-05242011-002-R

Patient TREATMENT DATA
Date Received: 09/27/2011 Patient Sequence Number: 1
#TreatmentTreatment Date
SCS LEAD: MODEL 3186
IMPLANT DATE:
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