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

Model Number 37602

Device Problems Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Low Battery (2584); Device Displays Incorrect Message (2591)

Patient Problems Distress (2329); Discomfort (2330); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Ambulation Difficulties (2544); Cognitive Changes (2551); Electric Shock (2554)

Event Type  malfunction  

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for parkinson's disease and movement disorders.It was reported that 2-3 years after the device was implanted, the patient experienced a gradual return of tremors.Follow-up with the health care provider (hcp) indicated that the patient was seen on (b)(6) 2016.During it visit, it was reported that the ins reached elective replacement indicator (eri), and the patient was experiencing an action tremor in her right hand.The patient also experienced ataxic gait, more trouble eating, drinking, and tying her shoes; she dropped a plate and was upset.It was reported that the patient also suffered from a learning disorder, a lowered level of cognitive functioning, and unrelated cancer that was being treated with anastrozole.The patient was seen again on (b)(6) 2016 as her implantable neurostimulator (ins) reached end of service (eos) and was off; the device was replaced the following day.It was also stated that the patient experienced a shocking sensation followed by a worsening of tremors earlier in the week.A full system check showed no further problems that included normal impedances and the patient did not report any further episodes of discomfort.The hcp stated that the "shocking was likely the deep brain stimulation (dbs) turning off from the ins depletion".The following concomitant medications were reported: anastrozole, medroxy progesterone, mupirocin 2% external ointment, phenobarbital, pravastatin sodium, primidone, vitamin d tabs.

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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5943806
• MDR Text Key: 54506010
• Report Number: 3004209178-2016-18725
• Device Sequence Number: 1
• Product Code: MHY
• 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: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• Device Model Number: 37602
• Device Catalogue Number: 37602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2016
• Date Device Manufactured: 09/22/2014
• 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