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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
Event Date 09/30/2014
Event Type  Injury  
Event Description

It was reported that the patient fainted and lost consciousness while being programmed at the doctor¿s office. The patient was sent to the emergency room (er) via ambulance. At the time of the report the patient was alive with no injury. The exact reason for the patient fainting was unclear, so additional information was requested. If additional information is received a supplemental report will be sent.

 
Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 7482a51, serial# (b)(4), implanted: (b)(6) 2007, product type: extension. Product id: 3387s-40, lot# v015431, implanted: (b)(6) 2007, product type: lead. (b)(4).

 
Manufacturer Narrative

 
Event Description

Additional information received reported that the cause of the event was not determined and it was not device related. No troubleshooting was necessary. The patient was fine shortly after the event and they had been since. The patient was receiving effective therapy at the time of this report.

 
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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 Key4185135
Report Number3004209178-2014-19995
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/30/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/20/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2014
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received10/15/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/12/2012
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: 10/20/2014 Patient Sequence Number: 1
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