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

Model Number 3228

Device Problems Detachment Of Device Component (1104); Impedance Problem (2950)

Patient Problem Inadequate Pain Relief (2388)

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 2: reference mfr.Report#: 1627487-2018-03716.It was reported ((b)(6)) the patient had an scs system implanted using a penta lead and ipg (unknown model) for bi-lateral lumbar-sciatica.During a surgical procedure (for an unknown reason) the surgeon experienced difficulties while extracting the two lead tail connections from the ipg (date of procedure is unknown).One tail was removed without issue.The surgeon reported resistance upon extracting the second tail, noting the connection was bent and one of the lead contacts remained in the header.The surgeon decided to connect the same penta lead to a new ipg (model 3772 sn (b)(4)).The surgeon decided to install the system (implant date unknown) with only one working side of the penta lead.The patient was not satisfied and the surgeon decided to remove and replace the system with a new penta lead and new prodigy ipg on (b)(6) 2018.The patient is now satisfied with therapy.Additional information has been requested; however it is unavailable at this time.

Event Description

Device 2 of 2.Reference mfr.Report#: 1627487-2018-03716.

Event Description

Device 2 of 2.Reference mfr.Report#: 1627487-2018-03716.

• 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: 7427201
• MDR Text Key: 105367364
• Report Number: 1627487-2018-03727
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 39 YR
• Patient Weight: 47