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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SOLETRA

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MEDTRONIC NEUROMODULATION SOLETRA Back to Search Results
Model Number 7426
Device Problems High impedance; Inappropriate Shock; Low impedance
Event Type  Malfunction  
Event Description

It was reported that the pt experienced a shocking sensation on the left side of their face which travels into hand and arm. The symptoms appeared following a tooth extraction on the right side of the pt's mouth. High and low impedances were reported. Impedances: c/0 >2000 8ua, c/1>2000 9ua, c/2 669 19, c/3 678 19 all bipolar pairs <50 and 223. Programmed c+1-, 2. 6v, 60 185.

 
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Brand NameSOLETRA
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 Key1463155
Report Number2182207-2009-04795
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 06/16/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/13/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received06/16/2009
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: 07/13/2009 Patient Sequence Number: 1
Treatment
PROGRAMMER: MODEL UNK, LOT # UNK
LEAD: MODEL UNK, LOT # UNK
IMPLANTED:
IMPLANTED:
EXTENSION: MODEL EXTENSION, LOT # UNK
EXPLANTED:
EXPLANTED:
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