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

Model Number 37601

Device Problems Overheating of Device (1437); Insufficient Information (3190); Noise, Audible (3273)

Patient Problems Burning Sensation (2146); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 3387s-40, serial#: (b)(4), product type: lead.Product id: 3387s-40, serial/lot #: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that the patient was experiencing a loud clicking noise and could feel poking in their head and believes its the implant.Multiple other people heard the clicking noise.Additional information received from the consumer reported the cause of the clicking sound and poking in the head wasn't determined.The consumer had the device checked with normal impedance results.The issue hadn't reoccurred, so the consumer and symptoms were being followed.Additional information was received from a consumer who reported they had clicking noises coming from inside them along with heat coming from the leads on one side of their head (the consumer could feel the heat inside and out).The consumer met with the manufacturer¿s representative (rep), as instructed by their healthcare provider (hcp), but they were unable to figure out what it was.The issue didn't repeat itself or heat up again, but it was very uncomfortable where it was positioned.The next scheduled appointment was january 22nd.

• 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: 11148592
• MDR Text Key: 245119159
• Report Number: 3004209178-2021-00525
• 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: P960009
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/11/2021

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: 09/14/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/04/2021
• Initial Date FDA Received: 01/11/2021
• Date Device Manufactured: 03/21/2016
• 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: 69 YR