MAUDE Adverse Event Report: ABBOTT MEDICAL KIT IMPLANTABLE SLIM TIP LEAD, 90CM; DRG SLIM TIP LEAD

Model Number MN10450-90A

Device Problem Migration (4003)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer report number: 1627487-2020-49129.It was reported the patient's leads appeared superficial on fluoroscopy.As a result, the patient underwent surgical intervention on (b)(6) 2020 during which the leads were buried deeper and secured with stitching, resolving the issue.

Manufacturer Narrative

Correction: the corrections additional report 2 should not have been submitted.The coding was already correct in additional report 1.

Manufacturer Narrative

Based on the information provided, a device problem was not identified.As a result, a conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.

Manufacturer Narrative

Correction: section h6 investigation findings should have been 3221 instead of 213 in additional report 1.Section h6 investigation conclusions should have been 4315 instead of 67 in additional report 1.Section h10 additional narrative data should state "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." instead of what is stated in the additional report 1.All of these corrections are reflected in this additional report 2.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 90CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11069141
• MDR Text Key: 223588005
• Report Number: 1627487-2020-49130
• Device Sequence Number: 1
• Product Code: PMP
• Combination Product (y/n): N
• PMA/PMN Number: P150004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/05/2021

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: 08/01/2019
• Device Model Number: MN10450-90A
• Device Lot Number: AB2390
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/08/2020
• Initial Date FDA Received: 12/23/2020
• Supplement Dates Manufacturer Received: 01/06/2021; 01/25/2021; 02/05/2021
• Supplement Dates FDA Received: 01/20/2021; 01/25/2021; 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRG LEAD; DRG LEAD
• Patient Outcome(s): Other
• Patient Age: 30 YR
• Patient Weight: 86