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

Model Number 37612

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Tingling (2171); Discomfort (2330); Electric Shock (2554)

Event Date 12/21/2017

Event Type  malfunction  

Event Description

Information was received from the consumer regarding a patient with an implantable neurostimulator (ins) for essential tremor and movement disorders.It was reported that, on the way home after implant of the ins, the device started to shock the patient in their left arm.The family member tried to get the patient to go upstairs but they did not want to.The family member contacted the patient on (b)(6) 2017 and was told the shocking was still occurring.It was noted that the shocking only lasted a second but that it happened numerous times.The family member stated that on the way home, the patient¿s shocking intervals would get further and further apart but was still happening.It was also reported that the shocking did not occur while the patient was asleep but as soon as they woke up the shocking started to occur again (around 11 o¿clock).The family member did state that they could tell the shocking caused the patient some discomfort by the tone of their voice.They further stated that they know they can "cut it off" but would need to turn it back on so the patient did not shake ¿into oblivion¿.It was noted that evert time the patient was brought to the emergency room (er), they did not know what to do because they were not familiar with the implanted device.In addition, the family member reported they tried to call the patient¿s neurology clinic but they were having issues with the phone there and was to call them back.There were no further complications reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

(b)(6) has been removed.If information is provided in the future, a supplemental report will be issued.

Event Description

Follow-up information was received from the rep reporting that the shocking the patient was feeling was a normal transient parasthesia.The rep reported they had the patient turn their stimulation down and it corrected the issue.No further patient complications have been reported as a result of this event.

• 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: 7152276
• MDR Text Key: 96124237
• Report Number: 3004209178-2017-26755
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169105492
• UDI-Public: 00643169105492
• 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
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial,Followup,Followup
• Report Date: 02/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2018
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2018
• Date Device Manufactured: 02/24/2017
• 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: 79 YR