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

Model Number 3186

Device Problem Use of Device Problem (1670)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/09/2017

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 2: reference mfr.Report: 1627487-2017-07123.It was reported the patient experienced ineffective stimulation due to low impedances, as confirmed by the territory associate.Reprogramming attempts were unsuccessful.The patient may be pending surgical intervention.Primary and associated device details are unknown.Request for additional information has been sent.

Event Description

Device 1 of 5, reference mfr.Report: 1627487-2017-07123.Reference mfr.Report: 1627487-2017-08237.Reference mfr.Report: 1627487-2017-08238.Reference mfr.Report: 1627487-2017-08236.For clarification, it was reported the patient experienced ineffective stimulation due to low impedances beginning once new ipg was implanted (b)(6) 2017, as confirmed by the territory associate.Reprogramming attempts were unsuccessful.The patient may be pending surgical intervention.Although device information is now known for the primary and associated leads, the implant date remains unknown.Ipg and extensions have been added as follow up information indicates they may possibly be liable.

Manufacturer Narrative

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

• Brand Name: OCTRODE LEAD KIT, 60CM 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
• MDR Report Key: 7022792
• MDR Text Key: 91794678
• Report Number: 1627487-2017-07122
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3186
• Device Lot Number: 13798
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other