MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

Model Number 37612

Device Problems Electromagnetic Interference (1194); Failure to Deliver Energy (1211)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 08/28/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a couple weeks ago, they went to the dentist to get some work done and they used a drill.They stated that after they did the work, they could not feel any stimulation at all.The patient confirmed that stimulation was on, but they just could not feel any stimulation like they normally do.Dental scenarios compatibility information was reviewed and it was recommended the patient speak with their healthcare provider (hcp) regarding the event.The patient mentioned they have notified their hcp.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10560530
• MDR Text Key: 207750886
• Report Number: 3004209178-2020-16338
• Device Sequence Number: 1
• Product Code: MHY
• 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: 09/21/2020

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: 07/14/2012
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/18/2020
• Initial Date FDA Received: 09/21/2020
• Date Device Manufactured: 08/19/2011
• 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: 70 YR