MAUDE Adverse Event Report: ABBOTT MEDICAL LAMITRODE S-8 LEAD KIT, 60CM LENGTH; SCS LEAD

Model Number 3286

Device Problems High impedance (1291); Low impedance (2285)

Patient Problem Inadequate Pain Relief (2388)

Event Date 04/21/2021

Event Type  Injury  

Manufacturer Narrative

Event date is an estimate.

Event Description

It was reported that the patient's implanted lead has high impedances and low impedances on several contacts.It was noted that the patient bowls frequently.As result the patient may undergo surgical intervention on a later date.

Event Description

Additional information received indicated that the patient's lead was explanted and replaced on (b)(6) 2021.Effective therapy was established post-operative.

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 incident could not be conclusively determined.

• Brand Name: LAMITRODE S-8 LEAD KIT, 60CM LENGTH
• Type of Device: SCS LEAD
• Manufacturer (Section D): ABBOTT MEDICAL; 6901 preston rd; plano TX 75024
• MDR Report Key: 11803158
• MDR Text Key: 249952798
• Report Number: 1627487-2021-13866
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 05414734402231
• UDI-Public: 05414734402231
• 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,consum
• Type of Report: Initial,Followup
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2013
• Device Model Number: 3286
• Device Catalogue Number: 3286
• Device Lot Number: 3491201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 91