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

Model Number 37601

Device Problem Battery Problem (2885)

Patient Problems Stroke/CVA (1770); Loss of consciousness (2418); Ambulation Difficulties (2544); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient had been in hospice for 2 years on comfort care and had another stroke recently saying the patient was on meds (on morphine) and drips and doesn't have much longer to live.When asked if this was related to the device the caller said they had no idea, caller said this could be dbs related, the patient had been bed bound a year, patient doesn't ambulate, patient hadn't fallen or hit their head so cause of stroke was unknown.Patient was already in hospice care at this time and patient was evaluated and patient's right side of the mouth was droopy and never regained consciousness after that and has been like that for the past 5 days.Caller wants to know if having dbs on would impede with the dying process to where it could prolong the patient's suffering.Patient services (pss) reviewed that turning off the ins would be a medical decision.Caller said patient doesn't have a managing hcp and implant hadn't been checked in at least 5 years when they last had implant replaced.Caller said they checked implant and saw eri on (b)(6) 2022.Pss reviewed meaning of eri with caller.Caller said that they thought the implant would last 7-10 years so when ps explained what eri meant the caller said "that's crazy" and surprised that the implant was already at eri.Caller said they had never turned off dbs before, pss redirected caller to hcp.

• Brand Name: ACTIVA
• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS
• 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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 13315782
• MDR Text Key: 289183740
• Report Number: 3004209178-2022-00958
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 01/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2019
• Device Model Number: 37601
• Device Catalogue Number: 37601
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2022
• Date Device Manufactured: 10/12/2017
• 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 Outcome(s): Other
• Patient Sex: Female