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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 High impedance (1291)
Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)
Event Date 08/25/2021
Event Type  Injury  
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. Date of event is estimated. During processing of this incident, attempts were made to obtain complete patient information.
 
Event Description
Related manufacturer reference number: 1627487-2021-17233. It was reported that the patient's lead contacts were exhibiting high impedances. As a result, the patient's extensions were explanted and replaced. Surgical intervention resolved the issue.
 
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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 Key12522274
MDR Text Key273006445
Report Number1627487-2021-17234
Device Sequence Number1
Product Code LGW
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 company representative,health
Reporter Occupation
Type of Report Initial
Report Date 09/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/21/2020
Device Model Number3383
Device Catalogue Number3383
Device Lot Number6367764
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/22/2018
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: 09/23/2021 Patient Sequence Number: 1
Treatment
SCS EXTENSION
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