MAUDE Adverse Event Report: ABBOTT MEDICAL EXTENSION, DUAL 4 CHANNEL 60CM; SCS EXTENSION

Model Number 3346

Device Problem High impedance (1291)

Patient Problem Inadequate Pain Relief (2388)

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with the investigation results will be provided in the final report.

Event Description

It was reported that during a procedure (mfr ref #1627487-2020-48024) for ipg replacement , it was found that the leads had impedance issues addressing high impedances.As a result the extension was replaced and effective therapy was restored.

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.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 60CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10871860
• MDR Text Key: 217309791
• Report Number: 1627487-2020-48025
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• PMA/PMN Number: K032751
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2007
• Device Model Number: 3346
• Device Catalogue Number: 3346
• Device Lot Number: 40287
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 82