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

Model Number 37603

Device Problems Inadequacy of Device Shape and/or Size (1583); Malposition of Device (2616); Electromagnetic Compatibility Problem (2927)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

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 who was implanted with an implantable neurostimulator (ins) for parkinson's dual and movement disorders.It was reported the inss were 'honkers' and that they 'look like a robot' because they are petite.Caller asked if there was a smaller ins.It was also reported that the current inss were placed 'way differently' this time and they liked the way the previous inss were placed better.No patient symptoms or further complications were reported as a result of this event.Additional information was received indicating the implant is smaller and better placement would have been an improvement.It was also noted on (b)(6) 2019 the patient had back surgery, neurotech-neuromonitoring was used for five hours.This may have had a negative effect on their dbs.

Manufacturer Narrative

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

• 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: 8910740
• MDR Text Key: 154920627
• Report Number: 3004209178-2019-15969
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761088
• UDI-Public: 00613994761088
• 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,Followup
• Report Date: 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/27/2019
• Date Device Manufactured: 10/22/2017
• 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: 66 YR
• Patient Weight: 60