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

Model Number 37603

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Headache (1880); Nausea (1970); Discomfort (2330); Electric Shock (2554)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: event date approximate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for essential tremor and movement disorders.It wa s reported that they had been experiencing shocking at the back of their head that was very uncomfortable and not related to positional movement.They were also experiencing very bad headaches which was making them sick to their stomach.A head scan was performed and their doctor (hcp) said they needed two revisions that couldn't be done at the same time.The patient called the hcp office multiple times and left messages but hasn't been called back yet.It was unknown if a surgery had been scheduled or not.There were no falls, trauma, or other medical tests prior to the head scan.The caller was redirected to follow-up with the hcp and/or surgical facility in regards to the surgery schedule.No further complications were reported or anticipated with this event.Refer to manufacturer report #3004209178-2019-08706 for details pertaining to the related reportable 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: 8570785
• MDR Text Key: 143743753
• Report Number: 3004209178-2019-08707
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2017
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/30/2019
• Date Device Manufactured: 03/10/2016
• 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): Required Intervention
• Patient Age: 67 YR