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 Muscle Weakness (1967); Paraplegia (2448)

Event Date 03/22/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.(b)(4).

Event Description

It was reported the patient underwent surgical intervention to address lead migration (reference mfr.Report: 1627487-2016-01782) and in the recovery room, prior to turning the stimulation on the nurse noticed right sided weakness.In addition, within a few minutes the patient experienced left sided weakness.The patient returned to the o.R.Where the lead incision was opened and the surgeon noted no anomalies, however the physician made a minor adjustment to the lead position.The patient was awaken and could not move her lower extremities and experienced a loss of sensation.The patient returned to the o.R.Where the scs system was explanted.The patient regained feeling and movement in both legs postoperatively in the recovery room.An mri was taken and showed no anomalies.Follow up information identified the symptoms were improving though have not completely resolved.The patient remained in the hospital.

Event Description

Follow up information identified the patient's weakness and loss of sensation have resolved.In addition the patient was hospitalized for a few days (exact number unknown) following the procedure.

• 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: 5571554
• MDR Text Key: 42489913
• Report Number: 1627487-2016-01784
• 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
• Report Date: 04/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 3228
• Device Lot Number: 5300924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2015
• 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): Hospitalization; Other
• Patient Age: 42 YR