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

Model Number 37601

Device Problems Electromagnetic Interference (1194); Vibration (1674); Electromagnetic Compatibility Problem (2927)

Patient Problems Neurological Deficit/Dysfunction (1982); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331)

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 who reported they had a ¿deep drone humming sensation/vibration and increasing dystonia symptoms in a new home; the deep brain stimulation (dbs) battery showed okay.The consumer stated there was a security system they never had with a magnetized ¿window¿ three feet from their bed, their son used wireless speaks/ipod in their old home with thick concrete walls while the new home had thin one.In addition, they just purchased a new scanning device and there was a garage door opening system they never had along with a second land line phone unit on their bed stand.The consumer was looking for assistance with what the problem might be or if they should look around the property to discover the issue or ask their neighbors about any radio transmission.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10385077
• MDR Text Key: 202212748
• Report Number: 3004209178-2020-13740
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H020007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/10/2020

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: 03/14/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/07/2020
• Initial Date FDA Received: 08/10/2020
• Date Device Manufactured: 09/17/2015
• 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