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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 37612
Event Type  Injury  
Event Description

Additional information received reported the time frame of the event was one to two years ago. The patient's device was turned off accidently, but the patient was turned back on and the issue was resolved.

 
Event Description

It was reported that one time the device turned off within the last 2 years prior to the date of this report and the patient was sent to the hospital due to the fact the he got to the point where he could not move, walk or talk, was diaphoretic and his blood pressure went up. This had not been within the last year prior to the date of this report, so it had happened prior to the last year. No interventions or outcome were reported. Further follow-up is being conducted to obtain this information. If additional information is received, a supplemental report will be submitted.

 
Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389-40, lot# j0357358v, implanted: (b)(6) 2004, product type: lead. Product id: 3389-40, lot# j0340483v, implanted: (b)(6) 2004, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. (b)(4).

 
Manufacturer Narrative

 
Manufacturer Narrative

Concomitant products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3389-40, lot# j0357358v, implanted: (b)(6) 2004, product type: lead. Product id: 3389-40, lot# j0340483v, implanted: (b)(6) 2004, product type: lead. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 748240, serial# (b)(4), implanted: (b)(6) 2004, product type: extension.

 
Event Description

Additional information received reported that the patient had therapy for a long time and had done well with it. Facility that the patient was in was educated on the device/therapy. No new information on loss of effect.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key4156403
Report Number3004209178-2014-18606
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 09/25/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/09/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date04/14/2011
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received11/19/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/14/2010
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: 10/09/2014 Patient Sequence Number: 1
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