MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EONC; SCS IPG

Model Number 3688

Device Problem Battery Problem (2885)

Patient Problem Inadequate Pain Relief (2388)

Event Date 05/06/2014

Event Type  Injury  

Event Description

It was reported the pt ((b)(6)) is without stimulation and unable to communicate with the ipg via the programmer.Surgical intervention will be undertaken at a later date to address this issue.Based on the program settings provided, the life of the pt's ipg was estimated as 104 months.However, additional programming details are needed in order to provide a more concise longevity calculation.

Event Description

It was reported surgical intervention was undertaken to explant and replace the patient's ipg.Effective stimulation was recaptured following the procedure.

Manufacturer Narrative

Sjm has limited info related to the pt's medical history and is unable to form an opinion as to the relevancy of the pt's history to the event reported.Sjm defers to the pt'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.

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

Results: while the ipg was attached to a known good battery, it was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed.The complete programming history and usage was unknown.When averaging the two longevity estimates of 44 and 60 months, the average longevity would have been 52 months.The device was implanted for 38.7 months per the complaint record.Using the average longevity of 52 months, the device exceeded 85% of the estimated longevity at 38.7 months, and would be considered to have normal battery depletion.Electrical testing of the device confirmed normal operation while attached to a known good supply voltage.The root cause of the observation in the field of error codes and communication issues was due to a normally depleted ipg battery.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: EONC
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: courtney weddington ; 6901 preston rd.; plano, TX 75024 ; 9725264859
• MDR Report Key: 3850432
• MDR Text Key: 4406206
• Report Number: 1627487-2014-00320
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/03/2015

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: 04/01/2013
• Device Model Number: 3688
• Device Lot Number: 3371449
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2015
• Initial Date Manufacturer Received: 04/03/2015
• Initial Date FDA Received: 05/30/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/19/2015; 03/04/2015; 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: IMPLANT DATE:; SCS LEAD: MODEL 3186
• Patient Outcome(s): Other
• Patient Age: 77 YR