MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 10CM; SCS EXTENSION

Model Number 3341

Device Problem High impedance (1291)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 01/31/2019

Event Type  Injury  

Event Description

Device 4 of 4; reference mfr.Report#: 1627487-2019-02467, 1627487-2019-02468, 1627487-2019-02469.The patient is implanted with scs system for off-label use.It was reported that the patient experienced a change in stimulation since they fell and now have high impedance on their right peripheral lead and lamitrode lead.In turn, the patient may undergo surgical intervention to address this issue.

Event Description

Device 4 of 4; reference mfr.Report#: 1627487-2019-02467, 1627487-2019-02468, 1627487-2019-02469.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 10CM
• 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: 8347483
• MDR Text Key: 136454011
• Report Number: 1627487-2019-02470
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402279
• UDI-Public: 05414734402279
• 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,Followup
• Report Date: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2018
• Device Model Number: 3341
• Device Lot Number: 5641815
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2016
• 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: 39