MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION 8-CHANNEL ADAPTER, MDT, 60CM; SCS EXTENSION

Model Number 2316

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Seroma (2069)

Event Type  Injury  

Manufacturer Narrative

In the event the device is returned to the manufacturer, the reported event cannot be analyzed via laboratory testing.The manufacturer 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.The manufacturer defers to the patient's physician regarding medical history.

Event Description

Device 3 of 3.Reference mfr report #: 1627487-2018-02244.Reference mfr report #: 1627487-2018-02248.It was reported that the patient experienced pain at the ipg and extension site sometime in (b)(6) 2017.As a result, the patient underwent surgical intervention on (b)(6) 2018 wherein fluid was drained from the ipg site and an extension was replaced.Reportedly, there was no infection confirmed.

• Brand Name: 8-CHANNEL ADAPTER, MDT, 60CM
• 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: 7320816
• MDR Text Key: 101766806
• Report Number: 1627487-2018-02249
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/07/2019
• Device Model Number: 2316
• Device Catalogue Number: 2316
• Device Lot Number: 5881333
• Other Device ID Number: 05415067016683
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2017
• 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: 3288, SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Weight: 99