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.

Manufacturer Narrative

Although we reported the product was returned, the current disposition of the device is unknown and therefore currently unavailable for evaluation.An internal investigation has been launched for this issue.

Manufacturer Narrative

The reported event of lamitrode4 pullout/disconnection was confirmed.As received, the lamitrode was complete and terminal end electrode broken inside the dual extension port; consistent with reported event.The root cause is consistent with overstress condition that the lamitrode4 was subjected while in vivo.

• Brand Name: EXTENSION, DUAL 4 CHANNEL 10CM
• Type of Device: SCS EXTENSION
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 10809048
• MDR Text Key: 215284052
• Report Number: 1627487-2020-33470
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402279
• UDI-Public: 05414734402279
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 05/26/2021

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: 09/22/2019
• Device Model Number: 3341
• Device Catalogue Number: 3341
• Device Lot Number: 6139011
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/09/2020
• Supplement Dates Manufacturer Received: 03/16/2021; 05/24/2021
• Supplement Dates FDA Received: 03/17/2021; 05/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL # 3240 - LEAD (X2); MODEL # 3341 - EXTENSION; MODEL # 3240 - LEAD (X2); MODEL # 3341 - EXTENSION
• Patient Outcome(s): Other
• Patient Age: 20 YR
• Patient Weight: 91