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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 Loss of Power
Event Date 06/01/2009
Event Type  Malfunction  
Manufacturer Narrative

(b) (4).

 
Event Description

It was reported that the pt experienced a lack of therapeutic effect. The pt experienced tremors in their hands and "did not feel right". The pt programmer indicated that the pt's devices were no longer on. The pt was unable to turn devices back on. After repositioning the antenna, the pt was able to turn both devices back on. Refer to mfr report# 3004209178-2009-05190.

 
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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 ave
minneapolis , MN 55432-3576
7635263952
MDR Report Key1489320
Report Number3004209178-2009-05191
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 06/30/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/28/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/28/2010
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received06/30/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/03/2008
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: 07/28/2009 Patient Sequence Number: 1
Treatment
EXPLANTED:
IMPLANTABLE NEURO STIMULATOR: MODEL 7426,
IMPLANTED:
EXPLANTED:
IMPLANTED:
EXTENSION: MODEL 7482A, LOT# NHU187273V,
EXPLANTED:
IMPLANTED:
EXPLANTED:
IMPLANTED:
PROGRAMMER: MODEL UNK, LOT# UNK
EXPLANTED:
IMPLANTED:
EXTENSION: MODEL 7482A, LOT# NHU164332V,
LEAD: MODEL 3389, LOT# J0519679V,
LEAD: MODEL 3389S, LOT# V129480,
LOT# NFW144936H,
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