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

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.

• Brand Name: EON MINI IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: TOTALLY 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 Key: 2289444
• MDR Report Key: 2269280
• Event Key: 2166175
• Report Number: 1627487-2011-04257
• Device Sequence Number: 1
• Product Code: LGW
• 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 Received: 09/27/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: Health Professional
• Device EXPIRATION Date: 10/01/2011
• Device MODEL Number: 3788
• Device LOT Number: 2864606
• Was Device Available For Evaluation?: Yes
• Date Returned to Manufacturer: 09/06/2011
• Is The Reporter A Health Professional?: No
• Event Location: AMBULATORY SURGICAL Facility
• Was The Report Sent To Manufacturer?: No
• Date Manufacturer Received: 08/30/2011
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 10/01/2009
• 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 Number: 1627487-05242011-002-R

Patient TREATMENT DATA

Date Received: 09/27/2011 Patient Sequence Number: 1

#	Treatment	Treatment Date
SCS LEAD: MODEL 3186
IMPLANT DATE: