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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, 30CM SCS EXTENSION

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ABBOTT MEDICAL EXTENSION, 30CM SCS EXTENSION Back to Search Results
Model Number 3383
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Unspecified Infection (1930)
Event Date 05/20/2022
Event Type  Injury  
Event Description
Related manufacturer reference number: 3006705815-2022-14895, related manufacturer reference number: 1627487-2022-04264, related manufacturer reference number: 1627487-2022-04266. It was reported that the patient experienced infection. As such, such the incision sites was opened on (b)(6) 2022. Reportedly, the physician believed the infection was superficial and not around the implants. The patient was admitted and the infection was being treated with iv antibiotics. Later. Surgical intervention took place on (b)(6) 2022 wherein a wound debridement at the ipg pocket was done. Information indicates that the infection was at the patient¿s old ipg pocket (related manufacturer reference number: 3006705815-2022-01179) that had the lead and extensions only. Reportedly, the patient was not doing well. As such, the patient was kept overnight and the entire system was explanted on (b)(6) 2022 to address the infection. Reportedly, the infection is being treated with iv and oral antibiotics.
 
Manufacturer Narrative
Date of event is estimated.
 
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Brand NameEXTENSION, 30CM
Type of DeviceSCS EXTENSION
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 Key15164590
MDR Text Key297242971
Report Number1627487-2022-04265
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05414734402323
UDI-Public05414734402323
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 08/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/11/2022
Device Model Number3383
Device Catalogue Number3383
Device Lot Number7654409
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/14/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2020
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: 08/04/2022 Patient Sequence Number: 1
Treatment
SCS IPG
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