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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 Inappropriate Shock
Event Date 09/03/2008
Event Type  Malfunction  
Manufacturer Narrative

 
Event Description

The patient experienced a loss of therapeutic effect; a tremor had returned to her right hand. She felt a jolting sensation when the hcp attempted to interrogate her deep brain stimulator. There was no known incident or accident related to the complaint. The integrity of the circuit appeared normal. Palpation of the lead extension area did not replicate the jolting sensation. All bipolar and case-electrode impedance measurements were within normal limits. The device was programmed to 0-, 1+ with a impedance of 1451 ohms and a current of 31 microamperes. The hcp planned to get x-rays to determine if any connections were loose. Additional information has been requested. A follow-up report will be submitted if additional information becomes available.

 
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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
710 medtronic parkway
minneapolis , MN 55432-5604
7635050823
MDR Report Key1191178
Report Number3004209178-2008-06152
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/03/2008
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/26/2008
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/14/2009
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Event Location Other
Date Manufacturer Received09/03/2008
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/15/2007
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: 09/26/2008 Patient Sequence Number: 1
Treatment
LEAD: MODEL 3387
EXPLANTED:
IMPLANTED:
EXTENSION: MODEL 7482
EXPLANTED:
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