MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 10CM SCS EXTENSION

Model Number 3341

Device Problem Disconnection (1171)

Patient Problem Inadequate Pain Relief (2388)

Event Date 10/23/2020

Event Type  Injury  

Manufacturer Narrative

Date of the event is estimated the results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Related manufacturer reference number: 1627487-2020-33468, 1627487-2020-33469, 1627487-2020-33471. It was reported the patients right occipital lead pulled out of the extension and was damaged. Surgical intervention took place wherein the lead and extension was replaced to address the issue. Therapy was restored post-op. Note: it is unknown which lead pulled out and was damaged, as such both leads and extensions are being reported.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 10CM
• Type of Device: SCS 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: andrea deitz ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 10809048
• MDR Text Key: 215284052
• Report Number: 1627487-2020-33470
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (Y/N): N
• Reporter Country Code: US
• PMA/PMN Number: P010032
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE

Reporter Occupation

• Type of Report: Initial
• Report Date: 11/09/2020

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 11/09/2020
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: No
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 09/22/2019
• Device MODEL Number: 3341
• Device Catalogue Number: 3341
• Device LOT Number: 6139011
• 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 Received: 10/23/2020
• Was Device Evaluated By Manufacturer?: Device Not Returned To Manufacturer
• Date Device Manufactured: 09/22/2017
• 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: 11/09/2020 Patient Sequence Number: 1

Treatment

MODEL # 3240 - LEAD (X2); MODEL # 3341 - EXTENSION