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

Model Number 3186

Device Problems Device Stops Intermittently (1599); Low impedance (2285)

Patient Problems Fall (1848); Inadequate Pain Relief (2388)

Event Date 03/01/2017

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

Device 3 of 3: reference mfr report: 3006705815-2017-00578 & 1627487-2017-02803.It was reported the patient experienced a fall and the patient's scs stimulation was turning on and off since.A company representative met with the patient and troubleshooting of the patient¿s system revealed low impedance for all of the leads contacts.Follow up identified surgical intervention was taken, during the procedure the physician suspected fluid may have entered into the ipg header.In addition, the patient's ipg was inoperable, the physician replaced the ipg.Reportedly, stimulation therapy was restored postoperatively.

• 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: 6590507
• MDR Text Key: 75962729
• Report Number: 1627487-2017-02804
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2016
• Device Model Number: 3186
• Device Lot Number: 4409876
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2014
• 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 (X2), SCS ANCHOR
• Patient Outcome(s): Other
• Patient Age: 64 YR