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

Model Number 37601

Device Problems Premature Discharge of Battery (1057); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Distress (2329); No Known Impact Or Consequence To Patient (2692)

Event Type  Death  

Manufacturer Narrative

Other relevant device(s) are: product id: 37601, serial#: (b)(4) implanted: (b)(6) 2013, explanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2014, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2016, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2017, product type: implantable neurostimulator.Product id: 37601, serial#: (b)(4), implanted: (b)(6) 2020, product type: implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

A consumer reported the patient passed away on (b)(6) 2020 at a long-term care facility.The consumer was asked if the death was thought to be related to the device/therapy to which they stated ¿it could have been, the patient was under a lot of stress¿ due to having to get their implantable neurostimulator (ins) replaced so frequently over the last couple of years with the most recently replacement taking place on (b)(6) 2020.The consumer stated they couldn¿t say a ¿definite yes¿ that the death was related to the device/therapy and no autopsy was performed as they didn¿t ask for one, but the patient¿s ¿programming was set in a way they needed to have the battery changed.¿ when the patient needed replacement, they had a lot of appointments to get it approved which were difficult to get scheduled which started about six years ago.It was noted the patient was in a long-term care facility where they didn¿t provide ¿good therapy for the patient¿ and they stopped doing rehabilitation because ¿they¿ knew the patient had parkinson¿s and didn¿t think they would benefit from it.It was noted the patient was on a medication for their heart, amiodarone, and medication for their parkinson¿s, sinemet.The consumer stated there was no other relevant medical history for the patient and they didn¿t know if there were medical records leading up to the patient¿s death available.

Manufacturer Narrative

Note that the codes have been updated to reflect the correction and information received.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Event Description

Additional information received from the healthcare provider (hcp) reported the implant depleted once every year as the patient¿s settings were on the higher end but were within normal.According to the hcp the depletions were expected due to the patient¿s therapy settings.The hcp noted that for years they gradually adjusted the settings down, but the patient preferred higher levels so their device wasn't turned down much.According to the hcp the patient decompensated in many ways and declined greatly even when the dbs was fully functional, and the battery level was good.The dbs device/therapy did not contribute to the patient¿s passing.The patient had been using roughly the same settings for years and deconditioned greatly after developing heart problems.No further complications were anticipated.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10058337
• MDR Text Key: 191014511
• Report Number: 3004209178-2020-08598
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000175719
• UDI-Public: 00763000175719
• 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: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2021
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/13/2020
• Date Device Manufactured: 11/19/2019
• 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 Outcome(s): Death