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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 Insufficient Information
Event Date 12/19/2006
Event Type  Death  
Manufacturer Narrative

 
Event Description

It was reported that pt expired. The cause of death was unk. The device was returned to the mfr. It was reported that pt expired. The cause of death was unk. The device was returned to the mfr prior to donation. Refer to mfr's report # 3004209178-2009-6047.

 
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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 Key1463139
Report Number3004209178-2009-06048
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Other
Reporter Occupation UNKNOWN
Type of Report Initial
Report Date 07/30/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/27/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date11/14/2005
Device MODEL Number7426
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer07/30/2009
Event Location Other
Date Manufacturer Received07/30/2009
Was Device Evaluated By Manufacturer? No
Date Device Manufactured05/21/2004
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: 08/27/2009 Patient Sequence Number: 1
Treatment
EXPLANTED:
LEAD: MODEL 3389
EXPLANTED:
IMPLANTED:
EXPLANTED:
IMPLANTED:
EXTENSION: MODEL 7482
EXPLANTED:
IMPLANTED:
IMPLANTED:
PROGRAMMER: MODEL UNK
IMPLANTABLE NEURO STIMULATOR: MODEL 7426
IMPLANTED:
LEAD: MODEL 3389
EXTENSION: MODEL 7482
LOT # NFW121979H
EXPLANTED:
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