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

Model Number 37601

Device Problems Failure to Deliver Energy (1211); Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Irritation (1941); Tingling (2171)

Event Date 09/03/2019

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 patient with an implantable neurostimulator (ins) for the treatment of parkinson's dual and deep bra in stimulation (dbs) therapy indications.It was reported that the patient was at the neurologist's office yesterday and they turned on dbs for the first time.Ever since, the patient has been feeling a tingling/buzzing sensation "where the leads are" on the left side of their head, specifically from the incision on the head and down their neck.The sensationwas stated to be irritating, but not unbearable or uncomfortable.It was stated if the patient touched the left side of their head, the tingling would go away, then when they'd touch the left side of the head again, the tingling would come back.The patient stated the neurologist tried to get the patient to feel stimulation on their right side of the head, but was unsuccessful.The patient mentioned that the neurologist was using an "older machine" for programming.The neurologist was stated to think "one of the leads might not be right." the stimulation considerations were reviewed with the patient on the call and they were redirected to their primary healthcare provider (hcp).No further symptoms or complications were reported or anticipated with this 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: 9128437
• MDR Text Key: 160331983
• Report Number: 3004209178-2019-18543
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• 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: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• Date Device Manufactured: 02/25/2019
• 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: 55 YR