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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. KINETRA Back to Search Results
Model Number 7428
Device Problems Device remains implanted; Electro-magnetic interference (EMI), compatibility/incompatibility
Event Date 04/17/2009
Event Type  Malfunction  
Event Description

It was reported that the patient's speech problems were getting worse and the patient had pulling on their neck. The patient further reported a loss of efficacy and noted that her symptom had returned to pre-implant. The patient was having a difficult time with swallowing. The symptoms occurred after the patient went through airport security. Additional information received reported that the patient was seen and was fine. The patient was no longer having dystonia symptoms. The patient felt a tingly feeling when she tried to use a magnet with the physician's instruction, which must have turned the system on. The system was interrogated and impedances checked and all the parameters were normal. The device was on. It was felt the stimulator was turned off sometime during the patient's travelling.

 
Manufacturer Narrative

 
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Brand NameKINETRA
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 Key1432913
Report Number3004209178-2009-03496
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 04/17/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received05/15/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date06/28/2010
Device MODEL Number7428
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received04/17/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/12/2009
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: 05/15/2009 Patient Sequence Number: 1
Treatment
EXTENSION: MODEL 7482, LOT# NHU184038V
IMPLANTED:
EXPLANTED:
EXPLANTED:
EXPLANTED:
PROGRAMMER: MODEL UNK, LOT# UNK
LEAD: MODEL 3387S, LOT# V187428
IMPLANTED:
LEAD: MODEL 3387S, LOT# V163388
EXPLANTED:
EXTENSION: MODEL 7482, LOT# NHU178960V
IMPLANTED:
IMPLANTED:
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