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

Model Number 3789

Device Problems Charging Problem (2892); Unintended Movement (3026)

Patient Problem Weight Changes (2607)

Event Date 02/20/2015

Event Type  Injury  

Event Description

It was reported the patient's scs ipg charger displays the slow-flashing green led, indicating ipg-charging at a reduced efficiency.The patient stated the most recent recharge required about 3.5 hours to get to 75% full.A sjm representative met with the patient and confirmed the patient's ipg appears titled in the pocket.Also, the patient has lost approximately 20 pounds since the implant.Follow-up identified surgical intervention was undertaken on (b)(6) 2015 to revise the patient's ipg pocket.The physician made a new pocket to the side of the original pocket which was more superficial and level.

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
• MDR Report Key: 4666133
• MDR Text Key: 5728015
• Report Number: 1627487-2015-01139
• 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: 03/16/2015

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?: No
• Device Operator: Other
• Device Expiration Date: 09/30/2016
• Device Model Number: 3789
• Device Lot Number: 4793565
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2015
• Initial Date FDA Received: 04/07/2015
• 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, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 40 YR