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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 Problems Electromagnetic Interference; Malfunction
Event Type  Malfunction  
Manufacturer Narrative

(b) (4).

 
Event Description

It was reported that the pt experienced a loss of therapeutic effect following cauterization for a skin condition. It was noted that the pt experienced shaking in his hand. Further info is being requested from the hcp.

 
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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
7000 central avenue
minneapolis , MN 55432-3576
7635263952
MDR Report Key1476510
Report Number3004209178-2009-04609
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 06/08/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/07/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date07/28/2008
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/08/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/13/2007
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: 07/07/2009 Patient Sequence Number: 1
Treatment
EXPLANTED:
EXPLANTED:
IMPLANTED:
EXPLANTED:
EXTENSION: MODEL 7482A, LOT# NHU140163V
IMPLANTED:
PROGRAMMER: MODEL 7438, LOT# NHL020835P
IMPLANTED:
EXPLANTED:
IMPLANTED:
LOT# NFW140755H
IMPLATNABLE NEURO STIMULATOR: MODEL 7426
LEAD: MODEL 3387S, LOT# V017110
IMPLANTED:
LEAD: MODEL 3387S, LOT# V015947
EXPLANTED:
EXTENSION: MODEL 7482A, LOT# NHU140161V
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