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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: NEURO - VILLALBA ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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NEURO - VILLALBA ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 3389S-40
Event Type  Injury  
Event Description

It was reported that there was post-operative inflammation. It was noted that the patient was transient symptomatic post-operative with non-infectious hypo-density around the electrode. It was noted that approximately six days after implant the patient presented to the emergency room with confusion, nausea and vomiting. It was noted that the patient had severe gait and imbalance issues. It was noted that the patient had declined cognitive function along with confusion. It was noted that stealth with contrast head ct was performed to confirm diagnosis. It was noted that keppra and steroids were used to treat. It was noted that the issue resolved in 3 to 7 days. It was noted that another ct was performed on (b)(6) 2013 and the edema around the lead was resolved. It was noted that blood work was also performed. It was noted that there was no action required as a result of the event. It was noted that the patient was alive with no injury at the time of this report. It was noted that the battery had not been implanted yet. Additional information received reported that the lead was on the left side and there was swelling. It was noted that the patient had a complete right side system. Additional information received reported that the health care professionals (hcps) in the case were not saying the lead caused the issue. It was noted that the cause of the issue was unknown.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
NEURO - VILLALBA
call box 6001
villalba PR 00766
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55432
Manufacturer Contact
chad hedlund
7000 central avenue ne rcw215
minneapolis , MN 55432
7635149619
MDR Report Key3474770
Report Number6000153-2013-00286
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 11/01/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/18/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/30/2016
Device MODEL Number3389S-40
Device Catalogue Number3389S-40
Device LOT NumberVA0B0KV
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received11/01/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/23/2013
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: 11/18/2013 Patient Sequence Number: 1
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