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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 on the date of this report during an intra-operative troubleshooting they were using an external neurostimulator (ens) and twistlock to troubleshoot on the lead directly. When they had tested at 3. 0v, open circuit values on all of the 0 contacts and 1/3 and 2/3 were seen. Prior to the procedure the patient had a short on electrodes 2 and 3, 32 ohms. They disconnected and reseated the lead in the twistlock and it was noted that they were using the short stylet knob. Impedances were retested at 3. 0v following reconnecting and no values were out of range. They disconnected and had indicated they would replace the extension. The extension and the battery were replaced on the left side. All impedances were back in range and the patient was doing fine post-operatively. Patient therapy had resumed.

 
Manufacturer Narrative

Concomitant products: product id neu_ens_stimulator, serial # unknown, product type external neurostimulator; product id 7482a51, serial # (b)(4), product type extension; product id neu_ens_stimulator, serial # unknown, product type external neurostimulator; product id 3387s-40, lot # v818201, product type lead; product id 37085-60, serial # (b)(4), product type extension. (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 Key4409316
Report Number3004209178-2015-00540
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/22/2014
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2015
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Date Manufacturer Received12/22/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured09/05/2013
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: 01/12/2015 Patient Sequence Number: 1
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