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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 Battery Problem (2885)
Patient Problem Inadequate Pain Relief (2388)
Event Date 12/05/2022
Event Type  Injury  
Event Description
It was reported that the patient's ipg had reached end of life.Surgical intervention may take place at a later date.
 
Manufacturer Narrative
Date of event is estimated.Initial reporter name and address: phone number; (b)(6).
 
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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 Key16072054
MDR Text Key306369806
Report Number1627487-2022-07163
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeBR
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 03/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/11/2021
Device Model Number6662
Device Catalogue Number6662
Device Lot Number7124429
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2019
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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