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

Model Number 3341

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2019

Event Type  Injury  

Event Description

Device 2 of 8.Reference mfr report: 1627487-2019-03912; reference mfr report: 1627487-2019-03914; reference mfr report: 1627487-2019-03915; reference mfr report: 1627487-2019-03916; reference mfr report: 1627487-2019-03917; reference mfr report: 1627487-2019-03919; reference mfr report: 1627487-2019-03918.It was reported that during an ipg replacement on (b)(6) 2019 (reference mfr report: 1627487-2019-03907), one of lead had detached (confirmed via x-rays) from the extension header.In turn, the extension was explanted and replaced.Therapy was restored.

• 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8493563
• MDR Text Key: 141302651
• Report Number: 1627487-2019-03913
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3341
• Device Lot Number: A9238079911
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Weight: 109