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

Model Number 37603

Device Problem Electromagnetic Interference (1194)

Patient Problems Edema (1820); Hemorrhage/Bleeding (1888); Seroma (2069); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Type  Injury  

Event Description

It was reported that the patient presented in the last two weeks with enormous edema around one of his two leads.The patient also had some hemorrhage around the contact zone.The working diagnosis was an indolent infection, but the neuro radiologist felt the case looked more like a reaction to the lead, possibly ¿thermal¿ injury.The physician thought the lead may have possibly contributed to the infection.The lead was explanted and would be replaced in the future.Three days later it was reported that the patient was in the hospital because the infection was thought to be a concern.The infection was thought to be down the length of the lead and it was being cultured.The patient reported that last week he went through a metal detector at a courthouse with his system on and since then had been having trouble with his right side system.The patient¿s left arm was shaking badly.The implantable neurostimulator (ins) was not interrogated after the patient went through the metal detector because the lead was removed before they were aware of the issue.It was noted that no shock was mentioned when going through the system.The patient was told by the courthouse employee that the system was totally fine for him to go through after a bypass was requested because it was a ¿new¿ system.The issues occurred on (b)(6) 2014 and the patient went to the hospital the day after.The reporter noted that the therapy had been a huge improvement for the patient.Two days later it was reported that the doctor was concerned a new type of metal detector could possibly create adverse events with patients.The doctor was not sure if the patient¿s problems were caused by the metal detector, but wanted to consider all possible explanations.The patient reported feeling ¿different¿ a couple of days after (b)(6) 2014.A scan showed unilateral edema and fluid accumulation around the lead.The lead culture came back negative for an infection.The doctor was thus seeking alternate explanations and a ¿neuroradiologist¿ told him that it may be a thermal lesion.The doctor speculated and wondered if passing through a security metal detector could cause lesions.The patient was doing very well after explant.

Event Description

Additional information received reported that the reporter spoke to the patient the day prior to the report and he seemed to be clear and cognizant and spoke normally.There was no further information about the cause of the patient¿s issues.

Manufacturer Narrative

Concomitant products: product id 3389s-40, lot # va0e6gu, implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type lead; product id 37642, serial # (b)(4), product type programmer, patient; product id 3389s-40, lot # va0e6gd, implanted: (b)(6) 2014, product type lead; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension; product id 37603, serial # (b)(4), implanted: (b)(6) 2014, product type implantable neurostimulator; product id 3708660, serial # (b)(4), implanted: (b)(6) 2014, product type extension.(b)(4).

Event Description

Additional information received reported that the patient had a mri and brain culture "on thursday or friday." the patient was to be seen in office the day after the report and his therapy status would be verified as well.Later that day it was reported that one of the patient's "systems got fried going thru a metal detector." the reporter stated that the physician cultured the tissue, no infection was found, but noted the cause of the infection was the metal detector.It was unclear if there was an infection or not.At the time of the report it was unknown what the site looked like as the patient had not been heard from.The patient had not been seen or re-implanted either.

• 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: 3835878
• MDR Text Key: 4413316
• Report Number: 3004209178-2014-09714
• Device Sequence Number: 1
• Product Code: MHY
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2015
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2014
• Date Device Manufactured: 11/16/2013
• 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 Outcome(s): Hospitalization; Required Intervention