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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 37612
Event Date 07/20/2015
Event Type  Malfunction  
Manufacturer Narrative

Concomitant products: product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, lot# va069bc, implanted: (b)(6) 2013, product type: lead. Product id: 3387s-40, lot# va069bc, implanted: (b)(6) 2013, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2013, product type: extension. Product id: 37651, serial# (b)(4), product type: recharger. (b)(4).

 
Event Description

A manufacturing representative reported that a short was measured on electrodes 1/3 with an impedance of 130 ohms. The patient had no recent falls or trauma and they had no recent medical tests. No change in therapy was reported and the patient was getting the coverage they needed. The patient's indication for use is movement disorders. The electrodes with low impedances were used for programming therapy. The manufacturing representative had been contacted by the patient's health care provider (hcp) because they measured 150 ohms last week when they met with the patient. Impedance of 130 ohms was measured the day of this report. The manufacturing representative was not able to program around the short. The implantable neurostimulator (ins) recharging scheduled of charging for one hour every two days had not changed. At the time of this report, the patient planned to monitor things over time to see if the impedances change or therapy is compromised before doing any type of surgical intervention.

 
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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 Key5022093
Report Number3004209178-2015-16491
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Reporter Occupation
Report Date 07/29/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2014
Device MODEL Number37612
Device Catalogue Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/29/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/09/2013
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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