MAUDE Adverse Event Report: ABBOTT MEDICAL PENTA 3MM LEAD, 60 CM; SCS PADDLE LEAD

Model Number 3228

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 08/24/2021

Event Type  Injury  

Manufacturer Narrative

During processing of this incident, attempts were made to obtain complete event and patient information further information was requested but not received.

Event Description

Related manufacturer reference number: 1627487-2021-17359.It was reported that the cervical system was explanted for unknown reason.

Manufacturer Narrative

There was no reported event against the lead.The paddle lead was returned cut and incomplete.Two terminal end segments measuring 28.5cm each was received.Both segments showed indications of being fully inserted and secured inside the header of the ipg.Continuity testing did not identify and broken wires.No physical or functional anomaly that existed prior to explant that would contribute to device being explanted was observed.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS PADDLE LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 12549877
• MDR Text Key: 273879163
• Report Number: 1627487-2021-17360
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017253
• UDI-Public: 05415067017253
• 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,health
• Type of Report: Initial,Followup
• Report Date: 10/27/2021

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: 11/05/2021
• Device Model Number: 3228
• Device Catalogue Number: 3228
• Device Lot Number: 7238555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 09/29/2021
• Supplement Dates Manufacturer Received: 10/26/2021
• Supplement Dates FDA Received: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL 3660; MODEL 3660
• Patient Outcome(s): Other