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

Model Number 37601

Device Problems Energy Output Problem (1431); Battery Problem (2885)

Patient Problems Stroke/CVA (1770); Dementia (1808); Dysphagia/ Odynophagia (1815); High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914); Dysphasia (2195); Therapeutic Response, Decreased (2271); Complaint, Ill-Defined (2331); Shaking/Tremors (2515); Weight Changes (2607); Ptosis (2620)

Event Type  Injury  

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.It was reported that the patient had a stroke the other day and all of a sudden, patient has a lot of tremors now in both arms.It was stated that the patient had not had tremors for 10 years.The caller's daughter had an idea to use the patient programmer (pp) to turn the ins on or see if they could get the tremors to stop.When they checked the ins, they were seeing end of service (eos) on the screen.The meaning of eos was reviewed for the caller.It was reported that the patient could no longer swallow, mouth was crooked, left eye was droopy and patient had not been able to communicate for a long time and now especially hard, speech was garbled/soft.Patient was redirected to the health care professional (hcp) to discuss symptoms.It was noted that the patient was in the nursing home for three years now, in hospice care since (b)(6).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 a consumer reporting that the patient passed away and the patient's death is considered to be unrelated to the device/therapy.The caller reported that the previous monday the patient felt horrible.The caller noted that the patient lost so much weight from being in hospice for so long.The caller further states on tuesday, the patient couldn't take their food, medicine, or water because they couldn't swallow.The caller noted that they gave the patient morphine under the patient's tongue to stop the tremors.They stated they did not think the patient was in pain when they passed and for the last 3 years the patient was in a nursing home.The date of death occurred on (b)(6) 2018.The main cause of death was the patient's parkinson's disease.The caller read off the patient's death certificate as "cause of death parkinson's, other contributing conditions fully body dementia, coronary artery disease, and hypertension.The caller noted the patient had low blood pressure when they stood up, but never had any blockages in the heart, 90% parkinson's disease.The patient passed at a hospice/care facility.The patient was cremated the devices were explanted but will not be returned for analysis/disposal.It was added that the ins was a "miracle" to both the patient and the caller and provided "a lot of good years" for them.

Manufacturer Narrative

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

Event Description

Additional information was received from the consumer stating that there were no interventions taken to resolve the eos, because after the stroke the patient quickly declined.Patient had been under hospice care for 8 months at the time.The patient died 4 days after the stroke and the device reached eos.The tremors gradually went away with morphine.

• 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: 8138378
• MDR Text Key: 129497304
• Report Number: 3004209178-2018-27046
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00643169529786
• UDI-Public: 00643169529786
• 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,Followup
• Report Date: 03/06/2019

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: 04/28/2017
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/21/2018
• Initial Date FDA Received: 12/06/2018
• Supplement Dates Manufacturer Received: 02/18/2019; 02/25/2019
• Supplement Dates FDA Received: 02/22/2019; 03/06/2019
• Date Device Manufactured: 11/03/2015
• 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 Weight: 45