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

Model Number 37612

Device Problems Battery Problem (2885); Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Hip Fracture (2349); Limb Fracture (4518); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient's implantable neurostimulator (ins) isn't charged as something has happened with their recharger.The patient has a private caregiver who helps with recharging but on (b)(6) 2021, the patient fell, broke their arm and hip and went to the hospital.They didn't think the fall was related but read from the records that the patient was in their kitchen, lost their balance and sustained a fall due to tremor from parkinson's. the patient arrived at their facility on (b)(6) 2021 and the recharger didn't come with the patient.The patient cannot get in contact with their private caregiver.They didn't know what date the ins may have depleted or when it was discovered that the ins wasn't working.They didn't know if the patient had any other external equipment with them and stated they would like this resolved in the fastest way possible because the fact that patient isn't able to use dbs therapy is hampering their physical and occupational therapy.A replacement recharger was sent as it appears it is lost at this point.It was suggested looking to see if the patient has their handset/communicator with them as these would be needed in order to turn ins back on after recharging and indicated the local rep may be needed to turn ins on if patient doesn't have any handset/commun icator.

Event Description

Additional information received from the healthcare provider (hcp) who reported the fall was not caused by the dbs device or therapy.The cause of the implant not being charged was due to the patient forgetting to charge and/or losing their recharger.The implant was able to be recharged and the implant was working following it being depleted.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• 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: 12529777
• MDR Text Key: 273335981
• Report Number: 3004209178-2021-14400
• Device Sequence Number: 1
• Product Code: MHY
• UDI-Device Identifier: 00763000384357
• UDI-Public: 00763000384357
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2021
• Device Model Number: 37612
• Device Catalogue Number: 37612
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Date Device Manufactured: 11/17/2020
• 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 Age: 64 YR
• Patient Sex: Female