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

Model Number 37603

Device Problems Electromagnetic Interference (1194); No Device Output (1435); Device Difficult to Program or Calibrate (1496); Data Problem (3196)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 03/15/2019

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 healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins) for movement disorders.It was reported the patient had a post-op mri check, and the technician (tech) used an 8840 to turn the left ins to 0v and off.The tech could not turn the ins back on after the procedure, and when the programming was checked no electrodes were active.They saw 100 usec as the pulse width but the setting on record was 70 usec.The 8840 would not allow them to program 2-1- with c+, and there was only a greyed-out button.The patient had a return of symptoms due to the ins being off for the mri.The caller confirmed the patient was in current mode when they should have been in voltage mode.It was confirmed no interleaving was occurring.The caller was able to switch the patient back to voltage mode, turned the system on and the patient's symptoms were now under control.It was stated the caller was ultimately unsure if the programming changes were done by the mri tech or an ins issue.No further complications were reported or anticipated with the 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: 8432582
• MDR Text Key: 139204862
• Report Number: 3004209178-2019-05568
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864214
• UDI-Public: 00643169864214
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2019
• Date Device Manufactured: 03/08/2018
• 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: 48 YR