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

Model Number 3228

Device Problem High impedance (1291)

Patient Problems Failure of Implant (1924); Inadequate Pain Relief (2388)

Event Date 04/10/2024

Event Type  Injury  

Manufacturer Narrative

It was reported to abbott, a patient underwent a lead revision.Diagnostics showed all but 2 contacts had high impedance.The previous penta lead was explanted and replaced with a new penta lead.The patient lost therapy 6 months earlier.Effective therapy was restored.The results of the investigation are inconclusive as the device was not returned for evaluation.Based on the information received, a single definitive root cause for the issue encountered was unable to be conclusively determined.

Event Description

It was reported that the patient had high impedances on a majority of their scs paddle lead contacts.Surgical intervention was undertaken on (b)(6) 2024 wherein the patient's scs lead was explanted, replaced, and therapy was restored.

• Brand Name: PENTA 3MM LEAD, 60 CM
• Type of Device: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer (Section G): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• Manufacturer Contact: heidi syndergaard ; 6901 preston road; plano, TX 75024 ; 9723098000
• MDR Report Key: 19217163
• MDR Text Key: 341434402
• Report Number: 1627487-2024-08461
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05415067017253
• UDI-Public: (01)05415067017253(10)6464682(17)200521
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2020
• Device Model Number: 3228
• Device Lot Number: 6464682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/10/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/22/2018
• 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: SCS IPG (X1)
• Patient Outcome(s): Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 82 KG