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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SOLETRA

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MEDTRONIC PUERTO RICO OPERATIONS CO. SOLETRA Back to Search Results
Model Number 7426
Device Problem Inappropriate Shock
Event Date 09/20/2008
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

The pt experienced a shocking sensation in the morning for 2 hours. Then between 1 pm and 3 pm, it got worse; she was feeling the shocks every 10 seconds. The shocks were felt in the face, tongue, and right hand. The pt went to the emergency room and the stimulator was turned off. The pt had an appointment scheduled with her neurologist. Additional info has been requested, a follow-up report will be sent if additional info becomes available.

 
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Brand NameSOLETRA
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 PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
charlotte gasperlin
710 medtronic parkway
minneapolis , MN 55432-5604
7635050823
MDR Report Key1208444
Report Number3004209178-2008-06727
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 09/22/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/21/2008
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date05/14/2008
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received09/22/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured11/17/2006
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: 10/21/2008 Patient Sequence Number: 1
Treatment
EXTENSION: MODEL 7489
IMPLANTED:
EXPLANTED:
LEAD: MODEL 3387
EXPLANTED:
IMPLANTED:
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