MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION EXCLAIM LEAD, 60 CM; SCS LEAD

Model Number 3224

Device Problems Disconnection (1171); High impedance (1291); Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Date 07/27/2018

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 2 of 3.Reference mfr.Report#: 1627487-2018-07849.Reference mfr.Report#: 1627487-2018-07851.It was reported during an ipg replacement procedure on (b)(6) 2018 (reference mfr.Report#: 1627487-2018-0763), it was found the leads had pulled out of the ipg header.As such, the leads were reconnected to the new ipg.Intra-op testing revealed high and low impedance values on multiple lead contacts.However, the company representative used the valid lead contacts and was able to reprogram and provide the patient with effective stimulation therapy.

• Brand Name: EXCLAIM LEAD, 60 CM
• 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: jennifer shepard ; 6901 preston road; plano, TX 75024 ; 9725264657
• MDR Report Key: 7810244
• MDR Text Key: 118028300
• Report Number: 1627487-2018-07850
• 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
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2009
• Device Model Number: 3224
• Device Lot Number: 97352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2007
• 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 3383(2), SCS EXTENSION
• Patient Outcome(s): Other