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

Model Number 37601

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Muscular Rigidity (1968); Dyskinesia (2363); Shaking/Tremors (2515); Ambulation Difficulties (2544)

Event Date 01/01/2018

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 regarding a patient with an implanted neurostimulator (ins) for parkinsons dual and movement disorders.The caller reported that about 2 months ago, the patient had a sudden episode and they did not know what happened.The caller reported the patient was in bed and went into shaking and teeth chattering.The caller reported they got the patient programmer and checked the patient's ins, which said on and ok.The caller reported turning the patient's stimulation off and back on, after which the patient stopped shaking and the caller reported it was almost like it rebooted the ins.The caller reported the patient saw their managing healthcare provider (hcp) last thursday who checked the leads.The caller reported that the hcp turned the stimulation off for a second to see the patient's symptoms and see if they were like when they had their episode, but they were not.The caller reported that during the episode the patient had full blown dyskinesia.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Due to (b)(4) harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider (hcp).The hcp reported that the patient awakened with acute worsening of parkinsons symptoms such as rigidity and difficulty ambulating.The hcp reported that the patient's spouse checked the ins and saw it was on.The hcp reported turning it off and then turning it back on which resolved the symptoms.No further patient complications have been reported as a result of 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: 7575239
• MDR Text Key: 110463231
• Report Number: 3004209178-2018-12777
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994934604
• UDI-Public: 00613994934604
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

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: 09/14/2015
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/01/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 08/10/2018
• Date Device Manufactured: 03/25/2014
• 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: 57 YR
• Patient Weight: 104