MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PENTA 3MM LEAD, 60 CM; SCS LEAD

Model Number 3228

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

Patient Problems Fall (1848); Device Overstimulation of Tissue (1991); Inadequate Pain Relief (2388)

Event Date 04/25/2018

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 1 of 2, reference mfr.Report: 1627487-2018-05182.It was reported the patient experienced positional overstimulation after the patient fell on the ipg site.In addition, the patient experienced ineffective stimulation due to the issue.Reprogramming was attempted to no avail.Surgical intervention is planned to address the issue.

Event Description

Device 1 of 2: reference mfr.Report: 1627487-2018-05182.Follow-up identified no intervention is planned at this time due to the patient's insurance.

Event Description

Device 1 of 2.Reference mfr.Report: 1627487-2018-05182.Follow-up identified the patient underwent surgical intervention on (b)(6) 2018 to explant and replace the lead and ipg.

• Brand Name: PENTA 3MM 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: 7537394
• MDR Text Key: 109030092
• Report Number: 1627487-2018-04843
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2016
• Device Model Number: 3228
• Device Lot Number: 4711122
• Other Device ID Number: 05414734406246
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 05/23/2018
• Supplement Dates Manufacturer Received: 06/01/2018; 07/13/2018
• Supplement Dates FDA Received: 06/14/2018; 07/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/24/2014
• 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(2), SCS ANCHOR
• Patient Outcome(s): Other
• Patient Age: 61 YR