MAUDE Adverse Event Report: ABBOTT MEDICAL; SCS LEAD

Model Number NMD0002

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

During processing of this complaint, attempts were made to obtain complete device information.The unique device identifier (udi #) is unknown because the lot and part number were not provided the results/ method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the implantation procedure was abandoned after the patient stated bleeding near the tonsils after intubating.The patient is stable and well post-operatively.

Manufacturer Narrative

Based on the information provided a device problem was not identified, as a result a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

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.

• Type of Device: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10538799
• MDR Text Key: 207099153
• Report Number: 1627487-2020-31489
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup
• Report Date: 11/23/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: NMD0002
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 10/09/2020; 11/12/2020
• Supplement Dates FDA Received: 10/13/2020; 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 104