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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 37612
Event Type  Injury  
Event Description

It was reported the patient was having a revision because their healthcare professional (hcp) suspected that the electrode combination of 0 and 1 was shorted. Electrode impedances ran on the day of this report was 2766 ohms. Therapy impedance with 0 and 1 used was 2871 ohms. The manufacturing representative was not sure when the issue started or what the hcp saw to suspect there was a short. The patient had no shocking or jolting. The patient¿s wife thought the issue ¿comes and goes¿ and sounded intermittent. No symptoms or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Concomitant products: product id: 3389s-40, lot# va01pn5, implanted: (b)(6) 2012, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 37651, serial# (b)(4), product type: recharger. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2012, product type: extension. Product id: 3389s-40, lot# va01pn5, implanted: (b)(6) 2012, product type: lead. (b)(4).

 
Manufacturer Narrative

 
Event Description

Additional information received reported the extension was replaced. The issue was resolved after the replacement and the patient was doing well.

 
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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 Key4503157
Report Number3004209178-2015-02727
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/10/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/28/2015
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received04/07/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/04/2014
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: 02/10/2015 Patient Sequence Number: 1
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