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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 High impedance; Device remains implanted
Event Date 02/20/2009
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

It was reported that there was impedance reading greater than 2000ohms on some of the unipolar pairs. Using 1 and 2 was sound, but caused tingling in the right pointer finger when stimulation was on. All other bipolar pairs were open except 1 and 2. The pt had noticed tingling in her finger the last 6-8 weeks. The last programming session was in 2008. Additional info received reported that the cause of the pt's symptoms was unk. The pt had new pain or hand paresthesias. An x-ray was performed (2009) with ap skull view which showed the stimulation system was intact. There were no findings. The pt outcome was reported as a non-serious injury/illness.

 
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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 Key1415415
Report Number3004209178-2009-02133
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial
Report Date 02/26/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date08/14/2009
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received02/26/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/19/2008
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: 03/25/2009 Patient Sequence Number: 1
Treatment
LEAD: MODEL 3387
IMPLANTED:
EXPLANTED:
PROGRAMMER: MODEL 7438
EXPLANTED:
IMPLANTED:
EXTENSION: MODEL 7482
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