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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL SCS CONVENTIONAL IPG

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ABBOTT MEDICAL SCS CONVENTIONAL IPG Back to Search Results
Model Number NMD0005
Device Problem Wireless Communication Problem (3283)
Patient Problem Inadequate Pain Relief (2388)
Event Type  Injury  
Manufacturer Narrative
During processing of this complaint, attempts were made to obtain complete event, patient and device information. Event date is unknown. The results of the investigation are inconclusive as the device was replaced, and not returned for analysis. Based on the information received, the cause of the reported event could not be conclusively determined.
 
Event Description
It was reported that the patient has not had therapy for about a year. The ipg is inoperable and as a result, surgical intervention occurred on (b)(6) 2021 and the ipg was explanted and replaced. The patient has effective therapy post operatively.
 
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Brand NameSCS CONVENTIONAL IPG
Type of DeviceIPG
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 Key12516319
MDR Text Key272867065
Report Number1627487-2021-17148
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,consum
Reporter Occupation
Type of Report Initial
Report Date 09/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberNMD0005
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 Received09/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/22/2021 Patient Sequence Number: 1
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