MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION LAMITRODE TRIPOLE 16 LEAD, 60 CM; SCS LEAD

Model Number 3219

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

Patient Problems Incontinence (1928); Neurological Deficit/Dysfunction (1982); Weakness (2145)

Event Date 03/28/2015

Event Type  Injury  

Event Description

It was reported, the patient experienced weakness in his legs and difficulty in walking.The doctor in the er believed the weakness was due to a 3-level compression.As a result, the patient underwent a 3-level laminectomy to reduce pressure on his chord.The patient was admitted to a rehabilitation center after the surgery.The date of the procedure is unknown.

Event Description

Follow-up revealed a sjm representative attempted troubleshooting.The patient has effective therapy in needed area but the leg weakness has not resolved.

Event Description

Follow-up revealed an sjm representative performed programming.The patient has finished physical therapy and is doing much better.

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.

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.

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

Additional information received indicated that patient stated he experienced paralysis for 6 weeks and incontinence.Patient began to have incontinence while in rehab for the paralysis that occurred following the implant procedure in 2015.Patient said he remains incontinent but is not pursuing any treatment or action for the issue.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

• Brand Name: LAMITRODE TRIPOLE 16 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: 4704584
• MDR Text Key: 5720777
• Report Number: 1627487-2015-07214
• 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,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 07/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2016
• Device Model Number: 3219
• Device Lot Number: 4876942
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/13/2014
• 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: 3788, SCS IPG
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 91