MAUDE Adverse Event Report: ST. JUDE MEDICAL - NEUROMODULATION PRODIGY MRI¿ IPG, 16 CH, RECHARGEABLE; SCS IPG

Model Number 3772

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

Patient Problems Muscle Spasm(s) (1966); Undesired Nerve Stimulation (1980)

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.

Event Description

Device 1 of 2:reference mfr.Report#: 1627487-2015-25180.It was reported the patient ((b)(6)) experienced uncontrollable limb movement during a mri.As a result, the mri was immediately stopped and the patient remained stable.It was noted the physician failed to inform an sjm representative of the mri, so the ipg mri mode could be enabled.Additionally, it was stated the ipg was turned off during the mri.The date of event is unknown.

• Brand Name: PRODIGY MRI¿ IPG, 16 CH, RECHARGEABLE
• Type of Device: SCS IPG
• 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: 5238148
• MDR Text Key: 31671101
• Report Number: 1627487-2015-25179
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 3772
• Device Lot Number: 5023629
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• 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): Other
• Patient Age: 50 YR