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

Model Number 37601

Device Problems Intermittent Continuity (1121); Unexpected Therapeutic Results (1631); Low impedance (2285); Device Displays Incorrect Message (2591)

Patient Problem Ambulation Difficulties (2544)

Event Date 05/09/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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 a neurostimulator for parkinson's dual and movement disorders.It was reported that the patient's programmer had an "out of regulation" (oor) error code displayed, indicating their implantable neurostimulator (ins) could not output what was being requested.This code had shown up once a month ago and showed up again a couple days ago; it occurred a third time but the date was not specified.The patient also indicated that roughly one month ago they had a fall - there was no indication if this was related to the oor.The patient also had trouble walking for the past couple weeks.Lastly, the patient noted that the voltage on the programmer fluctuated between 3.1 and 2.86 every week he checked it.No further patient complications were reported as a result of this event.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a healthcare professional.It was reported that an out of regulation (oor) error code was seen on the patient programmer a week ago while checking the ins status and went away without intervention.A short on 0 and 3 of 31 ohms was also found and the other pairs ranged from 1048-1548 ohms.The therapy impedance for that side was 791ohms and programmed on c 1 and 2.It was noted that the short was a known issue before the replacement surgery.It was also reported that the patient was not feeling that the therapy was quite as good as it was prior to the replacement.The caller added that the patient also reported having a fall but was not sure what came first, the fall or the change in therapy.

Manufacturer Narrative

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

• 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: 6636765
• MDR Text Key: 77455847
• Report Number: 3004209178-2017-12725
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169100770
• UDI-Public: 00643169100770
• 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,Followup
• Report Date: 06/16/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2018
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/13/2017
• Date Device Manufactured: 04/18/2017
• 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