MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROTEGE IPG, 16-CHANNEL RECHARGEABLE; SCS IPG

Model Number 3789

Device Problems Disconnection (1171); Unintended Movement (3026)

Patient Problem No Information (3190)

Event Date 02/11/2015

Event Type  Injury  

Event Description

It was reported the patient's ipg was flipping inside of the ipg pocket site.It is unknown if the patient experienced loss of stimulation.Subsequently, the patient underwent surgical intervention on (b)(6) 2015, where the ipg was revised.It was noted during the revision, the patient's ipg located in her abdomen was disconnected from the lead and implanted in her left buttock.

Manufacturer Narrative

(b)(4).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: PROTEGE IPG, 16-CHANNEL RECHARGEABLE
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• Manufacturer Contact: jennifer shepard ; 6901 preston road; plano, texas 75040 ; 9725264657
• MDR Report Key: 4587833
• MDR Text Key: 5480093
• Report Number: 1627487-2015-23133
• 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: Other
• Type of Report: Initial
• Report Date: 02/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2016
• Device Model Number: 3789
• Device Lot Number: 4791147
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2014
• 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: MODEL 3228 (2), SCS LEAD, IMPLANT DATE; MODEL 3386 (4), SCS EXTENSION, IMPLANT DATE; MODEL 3789, SCS IPG, IMPLANT DATE
• Patient Outcome(s): Other
• Patient Age: 51 YR