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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 37603
Event Type  Injury  
Event Description

It was reported that the patient¿s whole system was being removed because of a short on the lead itself. The managing neurologist was unable to program around it. It was noted the patient had one lead implanted in their left vim. It was noted that electrode 0 and 3 showed 96 ohms. Refer to manufacturing report #3004209178-2014-05027 for the information pertaining to the patient¿s first ins that prematurely depleted due to the short.

 
Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: 2011-(b)(6), explanted: 2014-(b)(6), product type: implantable neurostimulator. Product id: 3387s-40, lot# v727699, implanted: 2011-(b)(6), product type: lead. Product id: 37085-60, serial# (b)(4), implanted: 2011-(b)(6), product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. (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 Key4777649
Report Number3004209178-2015-09256
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial
Report Date 05/13/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/18/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/28/2015
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Date Manufacturer Received05/13/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured12/13/2013
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: 05/18/2015 Patient Sequence Number: 1
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