MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 50CM; DRG LEAD

Model Number MN10450-50A

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/02/2023

Event Type  Injury  

Manufacturer Narrative

Section b3: event date is estimated.

Event Description

Related manufacturer report number:1627487-2023-05556, 1627487-2023-05557, 1627487-2023-05604 it was reported that during an explant surgery on (b)(6) 2023 wherein the physician was unable to remove approximately 2cm of the patient's s1 drg lead due to the lead portion being stuck solid inside of the patient.The patient may undergo surgical intervention at later date to remove the remaining s1 lead portion.

Manufacturer Narrative

It was reported that during an explant surgery the physician was unable to remove approximately 2cm of the patient's lead due to the lead portion being stuck solid inside of the patient.The patient may undergo surgical intervention at later date to remove the remaining lead portion.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 event could not be conclusively determined.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG 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: 18196173
• MDR Text Key: 328887827
• Report Number: 1627487-2023-05562
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150004
• 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,Followup
• Report Date: 12/01/2023

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: 01/20/2021
• Device Model Number: MN10450-50A
• Device Lot Number: 6820286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 11/29/2023
• Supplement Dates FDA Received: 12/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2019
• 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: DRG IPG (X1); DRG LEAD(X1)
• Patient Outcome(s): Other
• Patient Age: 35 YR
• Patient Weight: 86 KG