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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 Problems Inappropriate Shock; Implant, reprogramming of
Event Date 05/01/2007
Event Type  Injury  
Manufacturer Narrative

 
Event Description

It was reported that beginning in 2007, the pt experienced a range of "surges" from "mild to one that goes though me that makes me lurch/jump a little bit". The shocking was "not so bad" but as the pt began to keep track, he noticed the shocking/jolting "happening a dozen times a day". The pt had periodic shocks and feelings of electricity in the chest and down the left arm 'emanating from a wire". When the pt used the programmer to check the battery, he "felt a surge of electricity go through me". After experiencing a powerful jolt, the pt feels lightheaded for 10-20 seconds. The pt reported an increase in tremors in the right hand and shaking worse than prior to the implant. The pt stated he had, "reasonable handwriting and now barely able to sign my own name - big scribble". The pt had an appointment with the hcp, although the hcp felt there was no issue with the shocking and, the tremors were a progression of the disease. The pt additionally reported falling and fracturing his right hip, but did not feel it was due to the device, as he was having issues prior to the fall. Impedance readings were done with all monopolar readings within normal limits. Bipolar readings between 0 and 3 were >2000 ohms. X-rays showed no sign of a lead fracture. The battery was found to be at 3. 57 volts. The device was reprogrammed around the 0 contact. The pt had changed his hcp and was scheduled to replacement surgery.

 
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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 Key1286581
Report Number3004209178-2009-00184
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 12/15/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date10/14/2007
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received12/15/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/26/2006
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: 01/12/2009 Patient Sequence Number: 1
Treatment
EXTENSION: MODEL 7482
IMPLANTABLE NEURO STIMULATOR: MODEL 7426
LOT# NFW135956H
EXPLANTED:
EXPLANTED:
EXTENSION: MODEL 7482
EXPLANTED:
LEAD: MODEL 3387S
EXPLANTED:
LEAD MODEL 3387S
EXPLANTED:
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