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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37602
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 02/20/2015
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 338902836, lot# b9993681k, implanted: (b)(6) 2000, product type: lead. Product id: 338902836, lot# b9992982k, implanted: (b)(6) 2000, product type: lead. (b)(4).

 
Event Description

The healthcare professional of a foreign clinical study reported the patient had increasing mental problems. The patient was suffering from increased confusion, hallucinations, and disorientation. There was suspicion of parkinson dementia. The event resulted in a serious deterioration in the health of the patient and in permanent impairment of a body function or damage to a body structure. The patient was examined (b)(6) 2015 but no actions were taken. No surgical intervention was taken and no surgical intervention as planned. The event was considered ongoing. Patient medical history included diagnosis of parkinson's disease in 1985. The patient was currently taking movement disorder and or psychiatric medications. If additional information on intervention or outcome is received a follow-up report will be sent.

 
Manufacturer Narrative

All fdp's removed and replaced. (b)(4).

 
Event Description

Additional information from the health care provider of the foreign clinical study reported the patient suffered from parkinson's dementia. The impairment was not related to the implant or the therapy.

 
Event Description

Additional information from the health care provider of the foreign clinical study reported patient outcome was death.

 
Event Description

Additional information from the health care provider of the foreign clinical study reported cause of death: heart failure with pulmonary edema. Not related to device or procedure. No implanted system components were returned to the manufacturer.

 
Event Description

Additional information received reported the outcome was unresolved at the time of death.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
road 31, km. 24, hm 4
ceiba norte industrial park
minneapolis MN 55432
Manufacturer Contact
lisa clark
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263920
MDR Report Key4993369
Report Number3004209178-2015-15822
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 01/17/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/11/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2015
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2017
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/09/2013
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 08/11/2015 Patient Sequence Number: 1
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