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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 37603
Event Type  Injury  
Manufacturer Narrative

Concomitant products: product id: 37603, serial# (b)(4), implanted: (b)(6) 2015, product type: implantable neurostimulator. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 37642, serial# (b)(4), product type: programmer, patient. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3387s-40, lot# va0p59t, implanted: (b)(6) 2015, product type: lead. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. Product id: 3708660, serial# (b)(4), implanted: (b)(6) 2015, product type: extension. (b)(4).

 
Event Description

A manufacturing representative reported the patient's wound was not healing properly where the lead and extension connection was located. The patient met with their health care provider (hcp) today for a wound check. A couple weeks prior to this report, the patient fell and went to the emergency room. The hcp in the emergency room had stapled over the head region close to the connector and lead location. During a revision to replace the extension and ins due to a short, irrigation and debridement was planned. The patient's indication for use is parkinson's dual and movement disorders. Following the revision, the patient had recovered without sequela. Refer to manufacturer report #3004209178-2015-16051.

 
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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 Key5004484
Report Number3004209178-2015-16054
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 07/21/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date05/14/2016
Device MODEL Number37603
Device Catalogue Number37603
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/18/2014
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: 08/14/2015 Patient Sequence Number: 1
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