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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
Event Date 04/15/2014
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 3389s-40, lot# va0ctzw, implanted: (b)(6) 2014, product type: lead. Product id: 3389s-40, lot# va0cs7a, implanted: (b)(6) 2014, product type: lead. Product id: 37085-60, lot# nkn060779v, implanted: (b)(6) 2014, product type: extension. Product id: 37085-60, lot# nkn060775v, implanted: (b)(6) 2014, product type: extension. (b)(4).

 
Event Description

It was reported that after the surgery the patient had been in a state of a coma. It was noted that after the patient regained consciousness the activities of the right lower limb was not flexible. It was noted that there was no patient death. Additional information received reported that the no diagnostics were performed, no malfunctions were seen, and no interventions were taken or planned. It was noted that the patient lived in the hospital now.

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, 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
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 Key3821544
Report Number3004209178-2014-09288
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 04/29/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/20/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date07/14/2015
Device MODEL Number37601
Device Catalogue Number37601
Device LOT NumberNKM722076H
Was Device Available For Evaluation? No
Date Manufacturer Received04/29/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured01/22/2014
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: 05/20/2014 Patient Sequence Number: 1
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