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); No Device Output (1435); Therapy Delivered to Incorrect Body Area (1508); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Muscular Rigidity (1968); Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Weakness (2145); Electric Shock (2554)

Event Date 01/18/2019

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 consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for parkinson's dual and movement disorders.The caller was wondering how to turn stimulation on because it seems like it was not working.It was stated that when the patient lost therapy, they froze up.It was stated that patient was very weak and they did not know what to do.The patient ended up going to the emergence room (er) and they did not know what to do to help the patient, and the manufacturer did not get back to the patient so they went home.The caller stated they still did not know how to get the stimulation back on.The caller stated that he went to try to work on it the day after and when they hit the cream button they thought they got it back on because the patient felt the stimulation/shock in their brain like it was working, because patient was better again momentarily.It was reviewed for the caller how to turn stimulation on with the patient programmer (pp) and the caller reported seeing the charger your ins battery warning message.Caller connected with the ins recharger (insr) , stated there was no lightning bolt on the ins icon.The ins battery was flashing first quartile, but after instruction from the patient services specialist (pss) they were able to reposition antenna and saw 8 bars.Caller noted that they did not know how to use the equipment.The caller was directed to charge the patient's ins battery until it was at least 25% full/solid before attempting to turn stimulation back on.The importance of maintaining the ins charged to prevent discharge from happening again was reviewed for the caller.It was stated that patient went to see a different doctor and they were getting a bunch of error codes and stuff, but the caller could not clarify further.The caller stated they did not know what the issues were but he took a long time, the caller further stated that the patient thinks the doctor messed it all up because they certainly did not help the patient.The caller stated that no one showed him or the patient how to work the equipment after the patient had a rechargeable ins implanted.It was recommended they request a meeting with the manufacturer's representative (rep) for additional training to over equipment use.No further patient complications were reported/ anticipated as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient stating that patient was able to turn the stimulation back on after charging the stimulator.Patient also reported that the symptoms resolved after turning the device back on.

• 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: 8331517
• MDR Text Key: 136897059
• Report Number: 3004209178-2019-02922
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169864238
• UDI-Public: 00643169864238
• 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: 04/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2019
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/25/2019
• Date Device Manufactured: 05/15/2018
• 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: 66 YR