MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37601

Device Problems Electromagnetic Interference (1194); Overheating of Device (1437)

Patient Problem Burning Sensation (2146)

Event Date 12/20/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot#: v264301, implanted: (b)(6) 2009, product type: lead.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2019, product type: implantable neurostimulator.Product id: 3389s-40, lot#: v264301, implanted: (b)(6) 2009, product type: lead.Other relevant device(s) are: product id: 3389s-40, serial/lot #: (b)(4), ubd: 03-sep-2011, udi#: (b)(4).Product id: 3389s-40, serial/lot #: (b)(4), ubd: 03-sep-2011, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that there was heating during magnetic resonance imaging (mri) of hip.The patient reported there was heating on the scalp and "pressed the ball" about 20 seconds into the scan, stopping the mri.The healthcare provider (hcp) wanted to make sure the mri eligibility form was completed properly.The hcp stated they would be reaching out to the patient to verify if an impedance test was performed and to determine what date the patient saw their managing hcp.The heating of the patients scalp was a sudden one-time event, 20 seconds into the start of the scan.The healthcare provider (hcp) used b1 + rms setting and it was confirmed by hcp's that the patient turned off the ins prior to mri.On 2019-12-23 crts (b)(4) (rep): a manufacturing representative (rep) reported the same information about the lead, heat, and the scalp.See general text for omitted information.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9613140
• MDR Text Key: 180175043
• Report Number: 3004209178-2020-01488
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/21/2020

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: 02/14/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/23/2019
• Initial Date FDA Received: 01/21/2020
• Date Device Manufactured: 08/21/2019
• 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: 78 YR