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 11/21/2017

Event Type  Injury  

Manufacturer Narrative

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.Manufacturer defers to the patient's physician regarding medical history.

Event Description

It was reported ((b)(6)) the patient experienced partial paraplegia following a system implant procedure.The patient had difficulty in walking, urinating and defecating due to muscle weakness.Ct scan performed did not reveal any anomalies.The patient was under observation for 48 hours.Follow up revealed the patient was recovering and symptoms were resolving.As of (b)(6) 2017 the patient was discharged and was admitted to the rehabilitation center.The physician confirmed the issues were not related to the device.

Event Description

Additional information received identified the patient¿s issues has resolved to about 80%.

Event Description

Additional information received clarified the patient has 90% improvement in his right arm and but only minor improvement on the left side.The patient still has a urinary catheter.

Event Description

Additional information received identified the patient is in rehabilitation center and recovering.The patient may undergo other medical treatments to resolve the issue.Additionally, the patient has reported multiple falls.Bowel and bladder impairment have yet to resolve.

• 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: 7105659
• MDR Text Key: 94432126
• Report Number: 1627487-2017-08254
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2018
• Device Model Number: 3228
• Device Lot Number: 5546915
• Other Device ID Number: 05414734401913
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2016
• 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