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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
Event Date 03/17/2015
Event Type  Injury  
Event Description

It was reported the patient was admitted to this hospital for a mental change and a kidney infection. The patient¿s healthcare professional (hcp) wanted a manufacturing representative to check to make sure the device was still functioning properly. The implantable neurostimulator (ins) was programmed on the left to 0-, 3+ at 4. 8v, 60 us, and 160 hz. Therapy impedance on the left side was measured to be 2638 ohms. Impedances on the left side, run at 1. 5v, were measured to be high with impedance of 2773 ohms being measured on electrode pair c-0. The left ins battery voltage was measured to be 2. 98v. The right ins was programmed to 1-, 3+ at 4. 5v, 60 us, and 180 hz. Therapy impedance on the right side was measured to be 2538 ohms. Impedances on the right side, run at 3v, were measured to be high on electrodes c-0, c-3, and 0-3. The right ins battery voltage was measured to be 2. 87v. No interventions or outcome were reported regarding this event. Further follow-up is being conducted to obtain this information. If additional information is received, a follow up report will be sent.

 
Manufacturer Narrative

Concomitant medical products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator. Product id: 3389-40, lot# j0406024v, implanted: (b)(6) 2004, product type: lead. Product id: 748251, serial# (b)(4), implanted: (b)(6) 2004, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2014, product type: extension. (b)(4).

 
Manufacturer Narrative

 
Manufacturer Narrative

 
Event Description

Additional information received reported the implantable neurostimulator (ins) was checked by a manufacturing representative while the patient is in a hospital to make sure it was working. No problems were found with the ins and the healthcare professional's goal was to rule out a deep brain stimulation problem as a cause of the patient's decline. No actions were taken and the issue was not device related.

 
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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 Key4664551
Report Number3004209178-2015-06062
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/17/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/07/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/28/2014
Device MODEL Number37602
Device Catalogue Number37602
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received05/08/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/04/2013
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: 04/07/2015 Patient Sequence Number: 1
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