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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC PUERTO RICO OPERATIONS CO. ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 37601
Device Problem Adverse Event Without Identified Device or Use Problem
Event Type  Injury  
Manufacturer Narrative

Concomitant medical products: product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted:(b)(6) 2015, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# va0j2e8, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3387s-40, product type: lead. Analysis of the leads found no anomaly for one (va0j2e8) and no significant anomaly for the other which was found to have the lead body¿s outer insulation cut.

 
Event Description

It was reported that there was an infection at the lead location. It was unknown what type of infection or if a culture was taken. It was unknown if antibiotic treatment was necessary. The entire system was explanted due to the infection. There was no alleged product issue. Additional information received indicated that they believed perioperative antibiotics were administered. It was unknown if the patient had meningitis. It was also unknown what treatment was instituted for the infection or what the patient outcome was. The patient had presented with slurred speech. All cultures had come back negative. Upon explant, one of the leads had edema throughout the entire ¿brain¿ section of the lead with more around the cortical end. The healthcare professional was wondering if there was some type of chemical on the lead that elicits a reaction at the implanted site and created an abnormal amount of edema causing a complication. Healthcare professional inquired about using a gas chromatograph on the explanted lead as part of analysis. No outcome was provided. Further follow-up is being conducted to obtain this information. If additional information is received a supplemental report will be submitted.

 
Manufacturer Narrative

Product id 3708660, serial# (b)(4), implanted: 2015 (b)(6), explanted: 2015 (b)(6); product type extension product id 3708660, serial# (b)(4), implanted: 2015 (b)(6), explanted: 2015 (b)(6); product type extension product id 3387s-40, lot# va0j2e8, implanted: 2015 (b)(6), explanted: 2015 (b)(6); product type lead product id 37642, serial# (b)(4); product type programmer, patient. (b)(6).

 
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Brand NameACTIVA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
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 Key4643373
Report Number3004209178-2015-05663
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/09/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/31/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date05/14/2016
Device MODEL Number37601
Device Catalogue Number37601
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer04/01/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/05/2015
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/25/2014
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: 03/31/2015 Patient Sequence Number: 1
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