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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR; DBS IPG

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ABBOTT MEDICAL INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR; DBS IPG Back to Search Results
Model Number 6662
Device Problem Wireless Communication Problem (3283)
Patient Problem Inadequate Pain Relief (2388)
Event Date 11/16/2022
Event Type  Injury  
Event Description
It was reported that during an initial implant procedure on (b)(6) 2022, the ipg became unable to communicate with external devices after the patient was closed.As a result, surgical intervention was taken on (b)(6) 2022 wherein the ipg was explanted and replaced to address the issue.
 
Manufacturer Narrative
A patient's ipg had a communication issue was reported to abbott.It was determined that during an implant procedure, a patient's ipg became unable to communicate with external devices after the patient was closed.As a result, the ipg was explanted and replaced to address the issue.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 event could not be conclusively determined.
 
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Brand Name
INFINITY¿ 7 IMPLANTABLE PULSE GENERATOR
Type of Device
DBS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
ronnie shalev
6901 preston road
plano, TX 75024
9723098000
MDR Report Key15955113
MDR Text Key305241280
Report Number1627487-2022-06522
Device Sequence Number1
Product Code MHY
UDI-Device Identifier05415067020260
UDI-Public05415067020260
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
P140009
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/24/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/10/2024
Device Model Number6662
Device Catalogue Number6662
Device Lot NumberT00004988
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/16/2022
Initial Date FDA Received12/09/2022
Supplement Dates Manufacturer Received01/23/2023
Supplement Dates FDA Received01/24/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/11/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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