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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
Event Date 04/05/2015
Event Type  Injury  
Event Description

It was reported that there was intracranial infection. The patient presented to the er with altered mental status, severe head and neck pain, and feeling like his insides were melting. The patient experienced in-patient hospitalization and an emergency room visit. Other surgical intervention was conducted including complete removal of bilateral electrode systems and generator. Perioperative antibiotics were administered specifically kefzol. The patient did not have meningitis. An organism culture showed staphylococcus aureus from the wound. Medication were administered specifically iv vancomycin and iv nafcillin on (b)(6) 2015. The outcome was noted as resolved without sequelae.

 
Manufacturer Narrative

Concomitant medical products: product id 3387s-40, lot# va0qxld, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead; product id 3387s-40, lot# va0nplb, implanted: (b)(6) 2015, explanted: (b)(6) 2015, product type: lead; 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. (b)(4).

 
Event Description

Additional information received reported that the patient experienced an intracranial infection in the right frontal lobe.

 
Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Additional information received reported imaging was done with abnormal results of right frontal lobe edema and rim-enhancing fluid collection along the course of the right deep brain stimulator, concerning adjacent infection with abscess formation. Imaging was also abnormal showing cephalomalacia involving right parieto-occipital region. Etiology was surgery/anesthesia. This had resulted in a life-threatening illness/injury and medical or surgical intervention to prevent life threatening illness/injury or permanent impairment to a body structure or a body function.

 
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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 Key4760034
Report Number3004209178-2015-08779
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Study,Health Professional,Company Representative,COMPANY REPRESENTATI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 05/04/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/08/2015
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? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/07/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/17/2014
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: 05/08/2015 Patient Sequence Number: 1
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