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

Model Number 37612

Device Problems Failure to Deliver Energy (1211); Device Operates Differently Than Expected (2913)

Patient Problems Device Overstimulation of Tissue (1991); Dysphasia (2195); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

Event Date 08/01/2017

Event Type  malfunction  

Manufacturer Narrative

Date of the event (b)(6) 2017 is an estimate.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for movement disorders.It was reported that the patient went to the health care professional (hcp)'s office on the day of the report and they discovered that the ins was off.The caller stated it was strange because patient had been doing really well lately and they had no clue when the ins would be turned off.The hcp turned it back on again at a very low dose because they had a suspicion that they were getting too much stimulation, further mentioning that the hcp was not sure because patient's symptoms had been improved over the last month or so.The caller stated that up until about a month ago, may be 5 weeks, they could not understand the patient's speech, further mentioning that the speech issues had been going on for a long time and the patient was kept at home as long they could.It was stated that the patient went to the nursing home in (b)(6) 2017, and before that their speech was getting difficult and got worse after patient got in the nursing home.A whole bunch of things were connecting with anxiety of going into the nursing home, patient had a ro ugh time for the first 3-4 months, then something happened where the patient's speech suddenly improved.Patient also started to show some minor tremors in their hands, those two things came at the same time and the only thing they could now attach it to was they had something to do with the ins being turned off.The caller stated that what they did not understand was why the patient looks so good right now, further mentioning it was amazing, you would not think they were sick.It was stated that for the last several months, patient had been doing really well, and everyone was surprised how well the patient was doing.No further patient complications were reported/ anticipated 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: 7491441
• MDR Text Key: 107751573
• Report Number: 3004209178-2018-10277
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529762
• UDI-Public: 00643169529762
• 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
• Report Date: 05/07/2018

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: 01/14/2016
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/03/2018
• Initial Date FDA Received: 05/07/2018
• Date Device Manufactured: 02/18/2015
• 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: 74 YR