MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXTENSION, DUAL 4 CHANNEL 60CM; SCS EXTENSION

Model Number 3346

Device Problem High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2019

Event Type  Injury  

Event Description

Related manufacturer reference number# 1627487-2019-06482.Related manufacturer reference number# 1627487-2019-06483.Related manufacturer reference number# 1627487-2019-06485.It was reported that system diagnostics revealed high impedances on one of the extensions during an ipg replacement procedure (related manufacturer reference number# 1627487-2019-06478).In turn, the extension was explanted and replaced.It is unknown which extension is related to the issue.Therefore, all the suspected devices are being reported.

Event Description

Related manufacturer reference number# 1627487-2019-06482; related manufacturer reference number# 1627487-2019-06483; related manufacturer reference number# 1627487-2019-06485.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 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
• Manufacturer Contact: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 8666580
• MDR Text Key: 146922340
• Report Number: 1627487-2019-06481
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032751
• 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: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2012
• Device Model Number: 3346
• Device Catalogue Number: 3346
• Device Lot Number: 3175283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2010
• 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 3346 (3), SCS EXTENSIONS
• Patient Outcome(s): Other
• Patient Age: 41 YR
• Patient Weight: 91