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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 Unknown (for use when the device problem is not known)
Event Type  Death  
Event Description

It was reported that the patient committed suicide as a result of complications and side effects from his implant surgery. The patient symptoms and side effects were: confusion, attention problems, choking, speech slurring, trouble forming words, weakness, increase in existing depression and sounds or sound sensation on the patient's left side of his head. He was active before the surgery, and after implant, he was never able to walk again. The patient's wife was unable to understand anything the patient would say. He often had a blank stare on his face for long periods of time. The day he committed suicide, he experienced sounds in his head, a whooshing sound on the left side of his head. It was noted that the patient had some depression before the surgery. Further information is being requested from the hcp.

 
Manufacturer Narrative

Slurred speech.

 
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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 Key1468877
Report Number3004209178-2009-06150
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 08/05/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/02/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date09/14/2010
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received08/05/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/17/2009
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: 09/02/2009 Patient Sequence Number: 1
Treatment
LEAD: MODEL 3387S
EXPLANTED:
EXPLANTED:
IMPLANTED:
EXTENSION: MODEL 7482A
IMPLANTED:
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