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

Model Number 3341

Device Problems Disconnection (1171); High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

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 1 of 3.Reference mfr.Report#: 1627487-2018-0957.Reference mfr.Report#: 3006705815-2018-00211.It was reported the patient stated while reaching for something on (b)(6) 2017, she heard a "pop" in her shoulder.The next day, the patient had lost stimulation.As such, a company representative met with the patient for reprogramming which initially resolved the issue.However, the issue reoccurred.Diagnostic testing revealed high impedance values on multiple lead contacts.Imaging revealed the extensions had pulled out of the port 1-8 and all lead contacts have high impedance values.As a result, the patient underwent surgical intervention on (b)(6) 2018 where the ipg was explanted and replaced.In addition, one extension was explanted and 3 were implanted.Please note, it is unknown which extension was explanted.Therefore, all suspected devices are being reported.

Event Description

Device 1 of 5- reference mfr.Report#: 1627487-2018-00957; reference mfr.Report#: 3006705815-2018-00211; reference mfr.Report#: 1627487-2018-03315; reference mfr.Report#: 1627487-2018-03316.Please note: two model 3383 extensions have been added to this report as ( devices 4 and 5).The analysis of the extensions revealed the device tested out of specification in a manner that relates to the reported event.

• 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
• MDR Report Key: 7242064
• MDR Text Key: 99040876
• Report Number: 1627487-2018-00955
• 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,Followup
• Report Date: 04/02/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 3341
• Device Lot Number: 5459843
• Other Device ID Number: 05414734402279
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/10/2018
• Initial Date FDA Received: 02/05/2018
• Supplement Dates Manufacturer Received: 03/07/2017
• Supplement Dates FDA Received: 04/02/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/13/2016
• 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
• Treatment: MODEL 1192(40, SCS ANCHOR; MODEL 3163 (4), SCS LEAD; MODEL 3383 (2), SCS EXTENSION
• Patient Outcome(s): Other
• Patient Age: 48 YR