MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 30CM; SCS EXTENSION

Model Number 3343

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Inadequate Pain Relief (2388)

Event Date 09/01/2019

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.Surgery date is estimated.

Event Description

Related manufacturer report number: 1627487-2020-49172.Related manufacturer report number: 1627487-2020-49173.Related manufacturer report number: 1627487-2020-49175.Related manufacturer report number: 1627487-2020-49176 related manufacturer report number: 1627487-2020-49178.Related manufacturer report number: 1627487-2020-49182.It was reported patient experienced ineffective therapy and the entire peripheral system was explanted on (b)(6) 2019.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 30CM
• 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: ronnie shalev ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 11066482
• MDR Text Key: 223437108
• Report Number: 1627487-2020-49181
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 05414734402293
• UDI-Public: 05414734402293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K000852
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/23/2020

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 Expiration Date: 08/31/2017
• Device Model Number: 3343
• Device Catalogue Number: 3343
• Device Lot Number: 5240607
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/23/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: MODEL 3166 X 2; MODEL 3169 X 2; MODEL 3343; MODEL 3789
• Patient Outcome(s): Other
• Patient Age: 49 YR
• Patient Weight: 59