MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC) PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

Model Number 3660

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

Patient Problem Paralysis (1997)

Event Date 10/13/2020

Event Type  Injury  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete event.The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 3006705815-2020-32394 and 3006705815-2020-32395.It was reported that the patient woke up and could not feel or move their legs.The patient was advised by their physician to turn therapy off.A stat mri was ordered for the patient but the patient¿s fever spike before the mri could be started.The patient was airlifted to a different facility where the scs system was explanted, the exact date is unknown.The patient is currently in a rehab facility recovering.

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 3006705815-2020-32394, 3006705815-2020-32395, 1627487-2020-47874, and 1627487-2020-47875.

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

Related manufacturer reference number: 3006705815-2020-32394, 3006705815-2020-32395, 1627487-2020-47874, and 1627487-2020-47875.

• Brand Name: PROCLAIM 5 ELITE IMPLANTABLE PULSE GENERATOR
• Type of Device: SCS IPG
• Manufacturer (Section D): ST. JUDE MEDICAL - NEUROMODULATION (PUERTO RICO, LLC); lot a interior - #2 street km 67.5; santana industrial park; arecibo PR 00612
• MDR Report Key: 10770447
• MDR Text Key: 214108050
• Report Number: 3006705815-2020-32396
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067031419
• UDI-Public: 05415067031419
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2022
• Device Model Number: 3660
• Device Catalogue Number: 3660
• Device Lot Number: A000098262
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL : 3186 (2); MODEL: 1192 (2); MODEL: 3186; MODEL: 3186
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 50 YR
• Patient Weight: 79