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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO., ACTIVA RC

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MEDTRONIC PUERTO RICO OPERATIONS CO., ACTIVA RC Back to Search Results
Model Number 37612
Device Problem Insufficient Information
Event Type  Malfunction  
Event Description

It was reported that the pt's leg went out on them and they fell and hit their head while throwing something over a chair. This was followed by a drawer falling on them. It was also reported that the pt experienced cramping in their torso, arm, hands, and knees to toes. The cramps were alleviated with walking around. The pt had a history of blood clots. Additional info has been requested from the hcp, but was not available as of the date of this report.

 
Manufacturer Narrative

(b) (4).

 
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Brand NameACTIVA RC
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 Key1494706
Report Number3004209178-2009-06001
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 07/29/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/26/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date12/28/2009
Device MODEL Number37612
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/29/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/02/2009
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: 08/26/2009 Patient Sequence Number: 1
Treatment
EXTENSION: MODEL 7482, LOT# NHU087448V
LEAD: MODEL 3387, LOT# J0511466V
EXPLANTED:
LEAD: MODEL 3387, LOT# J0454428V
IMPLANTED:
EXPLANTED:
EXPLANTED:
EXPLANTED:
IMPLANTED:
PROGRAMMER: MODEL 7436, LOT# NFU008575P
IMPLANTED:
IMPLANTED:
EXTENSION: MODEL 7482, LOT# NHU087445V
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