• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SOLETRA Back to Search Results
Model Number 7426
Device Problem Insufficient Information
Event Date 07/01/2009
Event Type  Injury  
Event Description

It was reported that the pt experienced a lack of therapeutic effect. The pt symptoms included distortion of her mouth and a tense and contorted right hand. The symptoms were not attributed to any accident of incident. The pt's implantable neurostimulator was turned off by the pt's husband, and as a result, the pt was unable to move. The pt was hospitalized. Reprogramming was not conducted due to pt's current medication. The pt's status was considered "fair". Add'l info has been requested from the hcp, but was not available as of the date of this report. Refer to manufacturer's report# 30042091782000906057.

 
Manufacturer Narrative

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key1462818
Report Number3004209178-2009-06058
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer,Company Representative
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 07/30/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/28/2009
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/28/2007
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Event Location Other
Date Manufacturer Received07/30/2009
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/11/2006
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: 08/28/2009 Patient Sequence Number: 1
Treatment
LEAD: MODEL 3389
EXPLANTED:
EXPLANTED:
IMAPLANTED:
EXTENSION: MODEL 7495-51
EXPLANTED:
MODEL 7426
IMPLANTED:
IMPLANTABLE NEURO STIMULATOR
EXPLANTED:
PROGRAMMER: MODEL UNK
IMPLANTED:
LEAD: MODEL 3389
EXTENSION: MODEL 7495-51
IMPLANTED:
EXPLANTED:
IMPLANTED:
-
-