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

MAUDE Adverse Event Report: GUIDANT PUERTO RICO BV ACCOLADE IMPLANTABLE PULSE GENERATOR

  • 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
 

GUIDANT PUERTO RICO BV ACCOLADE IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number U128
Device Problem Device Operates Differently Than Expected (2913)
Patient Problems Syncope (1610); Fall (1848); Ventricular Tachycardia (2132); Dizziness (2194)
Event Date 12/23/2017
Event Type  Injury  
Manufacturer Narrative
No additional information is available. If additional information becomes available the report will be updated at that time.
 
Event Description
Boston scientific received information that the patient reported multiple episodes of near syncope and chest pains due to tachycardia that required hospitalizations. The patient also reported that they had a syncopal event for an undefined reason where they fell to the floor hit their head, shoulder and arm. The patient further noted that they were unable to get up without help and has not been able to return to normal activities since the syncopal episode. The patient stated they reported the incident to their cardiologist, but was unable to obtain an appointment. The patient reported this information via a medwatch form mw5074950.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameACCOLADE
Type of DeviceIMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
GUIDANT PUERTO RICO BV
Manufacturer (Section G)
GUIDANT PUERTO RICO BV
Manufacturer Contact
tim degroot
4100 hamline ave. n
st. paul, MN 
6515826168
MDR Report Key7440118
MDR Text Key105803116
Report Number2124215-2018-06247
Device Sequence Number1
Product Code NKE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Patient
Type of Report Initial
Report Date 02/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberU128
Other Device ID NumberVALITUDE X4
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received02/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 04/18/2018 Patient Sequence Number: 1
-
-