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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Energy Output Problem (1431); Device Displays Incorrect Message (2591); Battery Problem (2885)

Patient Problems Therapeutic Effects, Unexpected (2099); Shaking/Tremors (2515)

Event Date 06/13/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient with an implanted neurostimulator (ins) for essential tremor and movement disorders.The caller reported that the patient's implant was off and their hands were shaking and all over the place when they woke up this morning.The caller reported syncing the ins with the patient programmer which showed the ins needed to be charged.The caller reported they were able to charge the implant, with 8 bars.The caller reported that the recharger was showing less than 1/4 charge.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Information references the main component of the system and other applicable components.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient indicating that the device does not turn off overnight, no matter how many hours patient sits to program it.The device does not stop the tremor totally, patient further stated that sometime the device goes off and they sit for a long period of time programming it.Patient stated that they called the manufacturer who walked them through turning it on and patient could not do it on their own since the patient's hand has never totally stopped the tremor, so the wife does it for the patient.

• 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: 7611539
• MDR Text Key: 111405592
• Report Number: 3004209178-2018-13700
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/30/2018
• Date Device Manufactured: 01/18/2016
• 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 Age: 86 YR
• Patient Weight: 73