MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS LEAD

Model Number 3219

Device Problem High impedance (1291)

Patient Problems Scar Tissue (2060); Inadequate Pain Relief (2388)

Event Date 04/11/2017

Event Type  Injury  

Manufacturer Narrative

Sjm 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.Sjm defers to the patient's physician regarding medical history.

Event Description

It was reported the patient was no longer receiving stimulation coverage from his scs system.Diagnostic testing revealed high impedance readings.During the surgical procedure on (b)(6) 2017, the physician removed scar tissue, then explanted and replaced the patient's lead.

Event Description

Follow-up information revealed effective therapy was restored following the procedure and the issue is resolved.

Manufacturer Narrative

Corrected data: concomitant products: patient does not have 2 model 2342 devices implanted as previously reported.

Event Description

Device 1 of 2: reference mfr.Report#: 1627487-2017-03535.The patient had 2 extension implanted as part of his scs system.The patient extensions have been added as a new device (device 2).Analysis of the extensions revealed the device tested out of specification in a manner that relates to the reported event.

• Brand Name: LAMITRODE TRIPOLE 16 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
• MDR Report Key: 6544051
• MDR Text Key: 74408268
• Report Number: 1627487-2017-02372
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2017

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: 06/30/2018
• Device Model Number: 3219
• Device Lot Number: 5560247
• Other Device ID Number: 05414734401821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/04/2017
• Supplement Dates Manufacturer Received: Not provided; 06/04/2017
• Supplement Dates FDA Received: 05/26/2017; 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• 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 2342(2), SCS LEAD
• Patient Outcome(s): Other
• Patient Age: 48 YR