MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE 44 LEAD KIT, 90CM LENGTH; SCS LEAD

Model Number 3262

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

Patient Problems Muscle Spasm(s) (1966); Inadequate Pain Relief (2388)

Event Date 12/17/2015

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 2: reference mfr report#1627487-2018-07910.It was reported that patient was unable to experience satisfactory coverage for pain in bilateral arms.Reportedly, patient did not use the cervical system in many years since she experienced muscle spasms when stimulation was turned on.Troubleshooting was attempted to no avail.As a result, surgical intervention may be pending to address the issue.

Event Description

Previous update regarding ipg revision does not pertain to this system, please disregard.Surgical intervention may still be pending to address the issue.

Event Description

Device 1 of 2.Reference mfr report# 1627487-2018-07910.Additional information revealed that the thoracic ipg was explanted and replaced on (b)(6) 2019.Postoperatively, patient has satisfactory coverage, however physician is still monitoring the coverage and may add another lead if needed.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Additional information revealed that the patient underwent surgical intervention wherein the ipg was explanted on 6jan2020 and a new ipg was implanted on (b)(6) 2020.Postoperatively, the patient has effective therapy.

• Brand Name: LAMITRODE 44 LEAD KIT, 90CM LENGTH
• Type of Device: SCS LEAD
• 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: seema wakdikar ; 6901 preston road; plano, TX 75024 ; 9725268205
• MDR Report Key: 7838188
• MDR Text Key: 118930826
• Report Number: 1627487-2018-07909
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2010
• Device Model Number: 3262
• Device Lot Number: 116742
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2008
• 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 3788, SCS IPG
• Patient Outcome(s): Other
• Patient Weight: 104