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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Device Problem Premature Discharge of Battery (1057)
Patient Problems Aspiration/Inhalation (1725); Death (1802); Dysphagia/ Odynophagia (1815); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271); Dyskinesia (2363); Respiratory Failure (2484); Shaking/Tremors (2515)
Event Date 07/03/2020
Event Type  Death  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the battery prematurely depleted and they had symptoms.There were no external factors associated to the event.Diagnostics/troubleshooting included an impedance check being performed, obtaining normal values.Interventions/actions included a therapy impedance was performed but with no results due to absence of therapy on the patient.The issue is not yet resolved.Symptoms included tremors and rigidity and dyskinesia.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep) stating that the patient had died, and the rep wanted to know what to tell the patient's relatives taking into account that it was due to the premature failure of the generator of the patient.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep) stating that taking into account, the relatives, and the treating doctor was very insistent for making the reports as fast as possible of what really happened with the device.It was also stated that with the exhaustion of the device, it was complicated, attributing to the complication.The manufacturer's representative (rep) did not have information on the current status of the device, as the patient was not cremated or buried with the device.Patient passed away on (b)(6) 2020.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from the manufacturer representative (rep) reporting that the device has not been returned as it is still implanted.The explant date has not been identified as a revision has not been planned yet.The cause of the premature depletion is not known.Actions/interventions taken to resolve the issue include therapy impedance being performed but with no results due to absence of therapy on the patient.The premature exhaustion of the battery was not resolved.This was confirmed with the physician.
 
Event Description
Additional information was received reporting that on the last day of the patient's consultation, the relatives reported that due to failures of the device, in this case "the premature exhaustion of the generator", their family member had become complicated since they could not eat or swallow food, as well as the sudden movements related to the symptoms of the parkinson's disease.They do not know the cause of the patient's death or if it was related to the device/therapy.They have not had any contact with the relatives and the treating doctor does not know anything about it.They have no further information about the patient, only from the family member that they had taken her to the emergency room because they had aspirated bronchial tubes and finally died of a cardio-respiratory arrest.The relatives wanted an explanation as to why the generator had not lasted as long as 2 to 5 years as their treating physician had told them, since it only had a useful life of 1 year.The patient had passed away while waiting for the authorization from their insurer to change the generator, she was unable to undergo surgery.They do not have information on the current status of the device, it is presumed that it was buried or cremated with the patient and they are unable to follow-up for the status.
 
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.
 
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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
MDR Report Key10233360
MDR Text Key197649269
Report Number3004209178-2020-11595
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
PMA/PMN Number
P960009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 09/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/06/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/28/2020
Device Model Number37601
Device Catalogue Number37601
Was Device Available for Evaluation? No
Date Manufacturer Received09/13/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age69 YR
Patient Weight62
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