MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA

Model Number 37601

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problems Headache (1880); Pain (1994)

Event Date 11/23/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 37601, serial#: (b)(4), implanted: (b)(6) 2019, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

On (b)(6) 2020 (b)(4) (con): it was reported that the patient had a cryoablation procedure of the nose to kill nerves.Patient reported, "when they stuck the thing up the nose to freeze the nerve, the reaction i had was most excruciating pain." he was in so much pain.Patient stated the cryoablation therapy place said they had not seen a reaction like that and also said it would be caused from the deep brain stimulation.Caller states they had to stop and could not do the stent part and it is being rescheduled.Additional information was received stating the patient had intense pain, specifically headache related to a cryoablation procedure.It was said that the physician administered gabopaten before the procedure and they had a headache 20 minutes after.

• Brand Name: ACTIVA
• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 11060889
• MDR Text Key: 223800337
• Report Number: 3004209178-2020-22483
• Device Sequence Number: 1
• Product Code: MFR
• UDI-Device Identifier: 00643169864191
• UDI-Public: 00643169864191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H050003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/11/2020
• Date Device Manufactured: 04/23/2019
• 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: 42 YR