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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 Inappropriate Shock
Event Date 05/07/2014
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id 748240, serial# (b)(4), implanted: (b)(6) 2003, product type: extension; product id 37642, serial# (b)(4), product type: programmer, patient; product id 3387-40, lot# j0225449v, implanted: (b)(6) 2003, product type: lead; product id 3387-40, lot# j0225449v, implanted: (b)(6) 2003, product type: lead. (b)(4).

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Analysis of the implantable neurostimulator (s/n (b)(4)) found no significant anomalies, the ins was functionally okay. Analysis of the extension (s/n (b)(4)) found the extension body outer insulation had breached depression.

 
Event Description

It was reported the patient had complained of being shocked in the chest from the device and they had a pain that would run down the left side of their body and down their left leg. It was noted the device was explanted on the day of report. It was stated a different product was used and the issue was resolved. It was noted the patient status at the time of report was alive with no injury. It was noted the patient had a burning sensation at the device pocket at the right side implant.

 
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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 Key3836594
Report Number3004209178-2014-09752
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,CONSUMER
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 05/07/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/28/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date04/14/2015
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/05/2014
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/25/2013
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: 05/28/2014 Patient Sequence Number: 1
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