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

Model Number 3341

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  Injury  

Manufacturer Narrative

Investigation results will be provided in the final report.

Event Description

Device 5 of 5.Reference mfr report # 3006705815-2019-00784.Reference mfr report # 1627487-2019-02869.Reference mfr report # 1627487-2019-02870.Reference mfr report # 1627487-2019-02871.It was reported that patient may undergo surgical intervention to explant the entire system.Reason for explant not yet provided.

Event Description

Device 5 of 5.Reference mfr report # 3006705815-2019-00784.Reference mfr report # 1627487-2019-02869.Reference mfr report # 1627487-2019-02870.Reference mfr report # 1627487-2019-02871.

Event Description

Additional information revealed that the patient underwent surgical intervention wherein the ipg was explanted and replaced due to difficulty by patient in using the system.Postoperatively, the patient has effective therapy and the issue has reportedly been resolved.As there was no allegation against the extension, the extension no longer needs to be reported on.

• 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: 8377418
• MDR Text Key: 137369191
• Report Number: 1627487-2019-02872
• 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,Followup
• Report Date: 07/09/2019

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: 11/28/2016
• Device Model Number: 3341
• Device Lot Number: 4879770
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/07/2019
• Initial Date FDA Received: 02/28/2019
• Supplement Dates Manufacturer Received: 05/02/2019; 06/25/2019
• Supplement Dates FDA Received: 05/02/2019; 07/09/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2014
• 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: 3166, SCS LEAD (2); 3186, SCS LEAD; 3771, SCS IPG
• Patient Outcome(s): Other
• Patient Weight: 82