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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7428
Event Type  Injury  
Event Description

It was reported that during pre-operation a short was found. The implantable neurostimulator (ins) was being replaced due to normal battery depletion. When the patient¿s ins pocket was opened up to change out the ins, the healthcare professional (hcp) discovered that a breast implant had ruptured and there was silicon in the pocket on the deep brain stimulation components. The hcp clean up the silicone, implanted the new ins, and impedances were fine. The hcp suggested the implant puncture was not related to the device, but was due to age. The patient¿s ins pocket was on their right shoulder. Prior to the replacement surgery the patient mentioned having a couple of falls. There were no concerns about the ins battery longevity.

 
Manufacturer Narrative

Product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 3387s-40, lot# v650839, implanted: 2011 (b)(6); product type lead product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension product id 7482a51, serial# (b)(4), implanted: 2011 (b)(6); product type extension. (b)(4).

 
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Brand NameKINETRA
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 Key4295195
Report Number3004209178-2014-22518
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/10/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/03/2014
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2012
Device MODEL Number7428
Device Catalogue Number7428
Was Device Available For Evaluation? No
Date Manufacturer Received11/10/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured02/02/2011
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: 12/03/2014 Patient Sequence Number: 1
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