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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNK DEEP BRAIN STIMULATOR

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MEDTRONIC NEUROMODULATION UNK DEEP BRAIN STIMULATOR Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem
Event Date 10/31/2009
Event Type  Injury  
Event Description

Literature: vanderhorst vg, papavassiliou e, tarsy d, shih lc. Early brain abscess: a rare complication of deep brain stimulation. Mov disord. 2009; 24(9): 1396-1397. Summary/reportable event: postoperative ct scan of the brain showed normal postsurgical changes immediately post-op. On postoperative day 3, the pt developed confusion and fever and was readmitted. There was no evidence of scalp infection at the surgical site. The pt had fluctuating inattentiveness, incoherent speech without aphasia, and left leg hyperreflexia. White blood cell count (wbc) was 15,000. Cerebrospinal fluid (csf) contained 135 wbcs, 359 rbcs, protein 51 mg/dl, glucose 98 mg/dl. Serial brain ct scans with and without contrast over the next 4 days were normal. Empirical treatment included intravenous vancomycin and meropenem. Blood and csf cultures remained negative. Repeated csf studies 4 days after readmission showed 46 wbcs, 216 rbcs, protein 71 mg/dl, and glucose 71 mg/dl. Temperature normalized but alertness continued to fluctuate. No new neurological signs developed. Brain ct scan on postoperative day 8 showed a hypodensity surrounding the right dbs electrode without ring enhancement. Brain mri on postoperative day 10 demonstrated a ring enhancing lesion with surrounding vasogenic edema in the right frontal lobe. Following mri, right frontal craniotomy showed no evidence of scalp or subgaleal infection. Reddish-gray material was found subcortically, cultures of which grew enterobacter aerogenes. The right electrode was removed. Antibiotic treatment was changed to intravenous ertapenem and was continued for 6 weeks. Mental status normalized within 2 weeks. Repeat mri at 6 weeks showed near resolution of the infection.

 
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Brand NameUNK DEEP BRAIN STIMULATOR
Manufacturer (Section D)
MEDTRONIC NEUROMODULATION
800 53rd ave n.e.
minneapolis MN 55421
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
800 53rd ave., n.e.
minneapolis MN 55421
Manufacturer Contact
charlotte gasperlin
7000 central ave
minneapolis , MN 55432-3576
7635263952
MDR Report Key1562460
Report Number3007566237-2009-08869
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Literature,Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 11/09/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/01/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received11/09/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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: 12/01/2009 Patient Sequence Number: 1
Treatment
IMPLANTED:
EXPLANTED:
IMPLANTED:
LEAD: MODEL 3387, LOT# UNK
EXPLANTED:
EXTENSION: MODEL UNK, LOT# UNK
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