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

Model Number 3688

Device Problem Unintended Movement (3026)

Patient Problem Twiddlers Syndrome (2114)

Event Date 05/01/2014

Event Type  Injury  

Event Description

Device 1 of 3.Reference mfr reports: 1627487-2014-03502 and 1627487-2014-03503.It was reported the patient was no longer receiving stimulation as her scs leads had broken and separated from the scs ipg which resulted from the patient manipulating the ipg within the pocket site.The scs leads were explanted and replaced which restored effective stimulation.It was also reported during the surgical intervention, the scs ipg was explanted and replaced with a rechargeable ipg per the patient's request.

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.

• Brand Name: EONC
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; plano TX
• Manufacturer Contact: rachel blackwell ; 6901 preston rd.; plano, TX 75024 ; 9725264637
• MDR Report Key: 3986546
• MDR Text Key: 4751538
• Report Number: 1627487-2014-03501
• 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: Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 07/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2014
• Device Model Number: 3688
• Device Lot Number: 3757241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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: SCS ANCHOR: MODEL 1192 (2); IMPLANT:
• Patient Outcome(s): Other
• Patient Age: 73 YR