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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY 5 IMPLANTABLE PULSE GENERATOR; DBS IPG
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ABBOTT MEDICAL INFINITY 5 IMPLANTABLE PULSE GENERATOR; DBS IPG Back to Search Results
Model Number 6660
Device Problem Device Damaged by Another Device (2915)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/19/2020
Event Type  Injury  
Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
 
Event Description
Related manufacturer reference number: 1627487-2020-33279.It was reported the patient experienced vibrations at the ipg sites during an mri scan.The scan was stopped once the patient reported feeling the vibrations.Therapy is still working and ipg communicates with external devices without issue.
 
Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
 
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Brand Name
INFINITY 5 IMPLANTABLE PULSE GENERATOR
Type of Device
DBS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
MDR Report Key10785771
MDR Text Key214571772
Report Number1627487-2020-33280
Device Sequence Number1
Product Code MHY
UDI-Device Identifier05415067020246
UDI-Public05415067020246
Combination Product (y/n)N
PMA/PMN Number
P140009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/19/2021
Device Model Number6660
Device Catalogue Number6660
Device Lot Number7188545
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received01/12/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
DBS IPG; DBS IPG
Patient Outcome(s) Other;
Patient Weight79
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