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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 37601
Event Date 06/14/2015
Event Type  Injury  
Event Description

Additional information received from the manufacturer representative (rep) reported that the shocking occurred on the patient¿s right side, or left brain. It was in the right shoulder and arm and considered sudden. It started on (b)(6) 2015 and occurred daily. Impedance measurements were taken and a short circuit was found on the electrode combination of 0 and 2. It was 90 ohms and the combination was being used in programming. In addition, the lead placement on that same side was not optimal, so an intended lead revision was scheduled for (b)(6).

 
Manufacturer Narrative

(b)(4).

 
Manufacturer Narrative

Concomitant medical products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# va01mbs, implanted: (b)(6) 2012, product type: lead. 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. (b)(4).

 
Event Description

It was reported there was a shocking/jolting sensation over their whole body for a few seconds two times within the same hour between 9-10am the day prior to report. The patient was in the bathroom and reached towards the medicine cabinet when it occurred. It had not occurred since and he never lost therapy. The battery was interrogated with his neurologist on the day of report. Impedance testing was performed and the results were normal and the device usage showed 100%. They had the patient move their head and arms and could not reproduce the symptom. No actions were taken. The patient was instructed to turn off the device if it ever became uncomfortable. The patient did not want to turn it off and lose the therapeutic benefits.

 
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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 Key4892107
Report Number3004209178-2015-12793
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/15/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/06/2015
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 Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received07/17/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured06/29/2012
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: 07/06/2015 Patient Sequence Number: 1
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