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

Model Number 37603

Device Problem Energy Output To Patient Tissue Incorrect (1209)

Patient Problems Tingling (2171); Shaking/Tremors (2515)

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 essential tremor and movement disorders.The patient reported that they had shaking in their left hand and arm.The patient reported that they could not see their healthcare provider (hcp) until (b)(6) 2018 and they were wondering if they broke the device or what they had done wrong.The patient reported that they changed their protocols in (b)(6) and (b)(6) and nothing had changed their shaking.The patient reported that the device implanted on the right side at one time in (b)(6) was set at 1.30v.The patient reported increasing it from 1.55 to 1.6v and they had not seen any improvement.The patient reported that their hcp did some testing in (b)(6) and the patient stated they had the sensation of tingling when the hcp adjusted the parameters but the shaking did not stop.The patient reported that they used to get the tingling sensation each time they jumped up the parameters but now they did not feel any tingling.The patient reported that after syncing with the patient programmer, they saw that stim was on.The patient reported that the right side showed 1.60v and the left side showed 1.40v.The patient reported that they were allowed to increase stimulation, but increasing/decreasing amplitude did not reso lve the issue.The patient reported that they had fallen a couple of times but didn't hurt anything, and they had not hit hard that they remembered.The patient reported the fall happened 2-3 months ago and that they had experienced the shaking before they had fallen.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Follow-up information was received from the healthcare provider (hcp) and the patient reporting that the tingling sensation was stimulation induced and that the issue was resolved by the patient turning their settings down.The patient reported that sometimes the tingling stops, but the tremors continue and have since january.The patient reported they have an appointment with the hcp scheduled for (b)(6)2018.The hcp reported that the issue was resolved, however the patient indicated that the issue had not resolved.Due to the conflicting information, it is unknown whether the reported issues have resolved.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: 7449899
• MDR Text Key: 106269872
• Report Number: 3004209178-2018-08551
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00613994761071
• UDI-Public: 00613994761071
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 37603
• Device Catalogue Number: 37603
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/01/2018
• Date Device Manufactured: 06/19/2015
• 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
• Patient Age: 72 YR
• Patient Weight: 87