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

Model Number 37601

Device Problems No Device Output (1435); Improper Device Output (2953)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 37642, serial# (b)(4), product type: programmer, patient.

Event Description

Information was received from a patient implanted with a neurostimulator for essential tremor and movement disorders.It was reported that the patient has been having trouble turning the device on and off.No further complications are anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the healthcare provider indicating that the aaa batteries in the programmer needed to be re placed.Once they were replaced, it was reporting to be functioning ok and the difficulty turning the device on/off was reported to be resolved.

• 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: 6927876
• MDR Text Key: 89942103
• Report Number: 3004209178-2017-21310
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169100770
• UDI-Public: 00643169100770
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/05/2017
• Initial Date FDA Received: 10/08/2017
• Supplement Dates Manufacturer Received: 12/06/2017
• Supplement Dates FDA Received: 12/22/2017
• Date Device Manufactured: 04/20/2017
• 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