MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problem Electromagnetic Interference (1194)

Patient Problems Burning Sensation (2146); Therapeutic Response, Decreased (2271)

Event Date 11/20/2014

Event Type  malfunction  

Event Description

It was reported that the patient was to have an mri of their brain on the day of report.Before the procedure, a manufacturer representative checked impedances and ¿did not find anything to be concerning.¿ the impedances were reported and they were all within normal limits.The patient turned their implantable neurostimulator (ins) off and had the mri.It was noted that the only thing the patient complained of initially was symptom return after the ins was turned off for the mri.It was stated that the patient then complained of their head heating up in the scanner after 14 minutes, so the health care professional (hcp) stopped the mri.The mri technician stated they were doing ¿t1, 3d [sagittal] fat¿ when they stopped the scan.It was further noted that the specific absorption rate (sar) was below 1%.It was reported that the patient¿s cheeks were cold but their head was warm, and that the patient ¿seems fine¿ but they still felt the sensation on the top of their head.The patient was to wait to turn the ins back on until they saw their doctor.No outcome was reported regarding this event.Further follow-up is being conducted to obtain this information.If additional information is received, a follow-up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 3387-40, lot# j0555411v, implanted: (b)(6) 2005, product type: lead.Product id: 748251, serial# (b)(4), implanted: (b)(6) 2005, product type: extension.Product id: 748295, serial# (b)(4), implanted: (b)(6) 2005, product type: extension.Product id: 3387-40, lot# j0555411v, implanted: (b)(6) 2005, product type: lead.(b)(4).

Event Description

Additional information received reported the patient's device was working fine.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; ceiba norte industrial park, r; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 4323683
• MDR Text Key: 21720612
• Report Number: 3004209178-2014-23810
• Device Sequence Number: 1
• Product Code: MRU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2014

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2014
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/25/2015
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/19/2015
• Date Device Manufactured: 03/25/2013
• 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 Age: 00059 YR