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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
Device Problem Device Displays Incorrect Message
Event Type  Malfunction  
Event Description

Additional information received from the manufacturer representative (rep) reported that the patient's battery was exchanged and no issues were found after that.

 
Manufacturer Narrative

 
Manufacturer Narrative

Concomitant medical products: product id 37602, serial# (b)(4), implanted: (b)(6) 2012, product type: implantable neurostimulator; product id 37642, serial# (b)(4), implanted: (b)(6) 2012, product type: programmer, patient; product id 3387s-40, lot# va02nm4, implanted: (b)(6) 2012, product type: lead; product id 7482a95, serial# (b)(4), implanted: (b)(6) 2012, product type: extension; product id 3387-40, lot# j0401949v, implanted: (b)(6) 2004, product type: lead; product id 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension; product id 7438, serial# (b)(4), implanted: (b)(6) 2004, product type: programmer, patient. (b)(4).

 
Event Description

It was reported the patient had a shocking sensation and shooting painful stimulation in their chest, arm, and hand. The patient was fine until about two weeks prior to this report. Over the weekend prior to this report, the patient went to the emergency room due to pain in their chest and a change in their issue. Stimulation was turned off in the emergency room and the pain went away. During the visit, an elective replacement indicator (eri) message was displayed. The implantable neurostimulator (ins) was at 2. 56v. A manufacturing representative met with the patient on the day of this report and the ins was turned off. Impedances were measured and there was nothing out of the ordinary. During the impedance measurement, the patient felt shooting pain. The ins was programmed to 1+, 2- at 4v, 90 usec, and 185 hz. No recent car accidents or falls were noted. The patient did not experience symptoms when the ins was turned off. The manufacturing representative attempted to turn stimulation on and they got to 1. 4v when the patient felt stimulation in their arm and hand. The patient had an appointment scheduled with a surgeon on (b)(6) 2015 to discuss replacement of the ins since the ins was at eri. No outcome was 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. Refer to manufacturer report #3004209178-2015-13638.

 
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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 Key4924887
Report Number3004209178-2015-13639
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative,COMPANY REPRESENTATIVE
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/30/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/20/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/14/2014
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/18/2012
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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