MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, 30CM; SCS EXTENSION

Model Number 3383

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Coma (2417); Post Operative Wound Infection (2446)

Event Date 05/12/2017

Event Type  Injury  

Manufacturer Narrative

The reported event cannot be analyzed via laboratory testing.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.

Event Description

Device 4 of 4: reference mfr report#1627487-2017-03086, reference mfr report#1627487-2017-03085, reference mfr report#1627487-2017-03106.The patient received two extensions with the same lot number.It was reported during permanent implant ((b)(6)) a hematoma was observed at the lead and extension site.Reportedly, the patient was unresponsive after the procedure.Due to infection concern, the scs system was explanted on (b)(6) 2017.Follow-up identified the patient will continue evaluation to confirm the issue.

Event Description

Device 4 of 4.Reference mfr report#1627487-2017-03086, reference mfr report#1627487-2017-03085, reference mfr report#1627487-2017-03106.Follow-up identified the patient recently expired due to an unrelated issue.The date of death is unknown.

• Brand Name: EXTENSION, 30CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ST. JUDE MEDICAL - NEUROMODULATION; 6901 preston rd; plano TX 75024
• MDR Report Key: 6633634
• MDR Text Key: 77318446
• Report Number: 1627487-2017-03087
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P010332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/27/2017

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: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 3383
• Device Lot Number: 5311049
• Other Device ID Number: 05414734402323
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/30/2015
• 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
• Patient Outcome(s): Other