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

Model Number MN10450-50A

Device Problems Migration or Expulsion of Device (1395); Migration (4003)

Patient Problem Inadequate Pain Relief (2388)

Event Date 06/18/2020

Event Type  Injury  

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.

Event Description

Related manufacturer reference number 1627487-2021-00288 and 1627487-2021-00287 it was reported the patient was unable to feel stimulation with the lead implanted at the s1 vertebral level, even with the amplitude being at maximum level.Amplitude for the leads implanted at the l4 and l5 vertebral levels was increased and the patient was able to receive therapy.Diagnostics did not reveal any impedance issues.All three leads were found to have migrated.Patient denied any trauma or falls.The drg system was explanted and replaced with an scs system.No complications were noted during the procedure and postoperatively, the patient is reportedly receiving effective therapy.

Manufacturer Narrative

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.

Event Description

Related manufacturer reference number: 1627487-2021-00288 and 1627487-2021-00287.

• Brand Name: KIT IMPLANTABLE SLIM TIP LEAD, 50CM
• Type of Device: DRG SLIM TIP LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11168066
• MDR Text Key: 226773224
• Report Number: 1627487-2021-00289
• Device Sequence Number: 1
• Product Code: PMP
• UDI-Device Identifier: 05415067027153
• UDI-Public: 05415067027153
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2021
• Device Model Number: MN10450-50A
• Device Catalogue Number: MN10450-50A
• Device Lot Number: 7034969
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MODEL KIT IMPLANTABLE SLIM TIP LEAD, 50CM; MODEL KIT IMPLANTABLE SLIM TIP LEAD, 50CM; MODEL KIT IMPLANTABLE SLIM TIP LEAD, 50 CM; MODEL KIT IMPLANTABLE SLIM TIP LEAD, 50 CM
• Patient Outcome(s): Other
• Patient Weight: 64