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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 Type  Malfunction  
Event Description

It was noted that the shocking was very brief but very reproducible, and there was some paraesthesia on that side as well.

 
Manufacturer Narrative

(b)(4).

 
Event Description

It was reported the patient had a shocking or jolting sensation. Since the patient¿s implantable neurostimulator (ins) was replaced in (b)(6) 2013 the patient had experienced significant shocks every time the ins was turned off with the patient programmer or during reprogramming. The healthcare professional (hcp) observed the shocks the day prior to this report when they were reprogramming the patient. The hcp stated the shocks were severe and lasted less than a couple seconds. The shocks were more severe when the ins was turned on. The patient felt the shocks on the left side of their face, arm, and leg. The hdp did not decrease stimulation before turn the ins off because it happened during reprogramming when they were changing the electrode configuration and the amplitude automatically dropped down to zero. The patient felt the shocks when the stimulation was at 0. 0v. The hcp stated that impedances may have been a little on the low side around 700-800 ohms, but nothing out of range. The patient was programmed at c+, 1- at 3. 5v, pulse width of 90, and a rate of 130 hz. The patient had previously been programmed at 4. 0v and a pulse width of 90. The ins was not programmed using interleaving and the ins was in voltage mode. Bipolar programming had not been tried. No interventions 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 medical products: product id 3387s-40, lot# v311441, implanted: (b)(6) 2010, product type: lead; product id 37642, serial# (b)(4), implanted: (b)(6) 2011, product type: programmer, patient; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension; product id 7482a66, serial# (b)(4), implanted: (b)(6) 2010, product type: extension. (b)(4).

 
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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 Key4393408
Report Number3004209178-2015-00242
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/16/2014
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date12/28/2013
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received02/23/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured07/13/2012
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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