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

Model Number 3789

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Date 03/30/2015

Event Type  Injury  

Event Description

It was reported surgical intervention was undertaken on (b)(6) 2015 during which time the scs system was explanted.Subsequently, the device was returned to the manufacturer after being explanted due to an unknown reason.However, the device tested out of specification during manufacturer's analysis.

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.Evaluation results: the system was explanted for unspecified reasons.The ipg was received in good condition.Performed autotest to ensure ipg electrical parameters were within specifications.The autotest ucod test step indicated that channel 8 was constantly high regardless of the input pattern.The can was cut open in order to troubleshoot the channel 8 failure.Channel 8 was shorted to ground.The short to ground was isolated to a zener diode d37.Zener diode (d37) is in the output coupling circuitry.During analysis, channel 16 feed through wire was broken.(b)(4).

• 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: melissa nkematu ; 6901 preston road; plano, TX 75024 ; 9723092520
• MDR Report Key: 4962071
• MDR Text Key: 6190217
• Report Number: 1627487-2015-08429
• 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: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2016
• Device Model Number: 3789
• Device Lot Number: 4759550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2015
• Date Manufacturer Received: 07/13/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• 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 3163, SCS LEAD; MODEL 3245, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 45 YR