• 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., JUNCOS 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., JUNCOS SOLETRA Back to Search Results
Model Number 7426
Device Problem Insufficient Information
Event Date 12/18/2009
Event Type  Injury  
Event Description

It was reported the patient's dbs stimulation device was turned off on (b) (6) 2009. The hcp was to increase the patient's medications until replacement could occur. The patient was admitted to the hospital (exact date unk but after (b) (6) 2009) for increased shaking, inability to swallow, and inability to sleep. Device replacement was originally scheduled for (b) (6) 2009, but due to blood clots the surgery did not take place until (b) (6) 2009. No information was provided on the reason for device replacement. (reference mfr report # 3004209178-2010-00952).

 
Manufacturer Narrative

(b) (4).

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSOLETRA
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
road #31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MDT PUERTO RICO OPERATIONS CO., JUNCOS
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 Key1614528
Report Number3004209178-2010-00953
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Consumer
Reporter Occupation NOT APPLICABLE
Type of Report Initial
Report Date 01/14/2010
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/10/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date02/28/2008
Device MODEL Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Device Age35 mo
Event Location Other
Date Manufacturer Received01/14/2010
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured09/06/2006
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: 02/10/2010 Patient Sequence Number: 1
Treatment
EXPLANTED:
EXPLANTED:
IMPLANTED:
EXTENSION: MODEL 7482, LOT #NHU001089N
PROGRAMMER: MODEL PROGRAMMER, LOT #UNK
IMPLANTED:
LEAD: MODEL 3387, LOT #J0236922V
-
-