MAUDE Adverse Event Report: ABBOTT DURATA STS OPTIM ACTIVE FIXATION; DEFIBRILLATION LEAD

Model Number 7122/65

Device Problems Signal Artifact/Noise (1036); Break (1069); High impedance (1291); Loose or Intermittent Connection (1371); Over-Sensing (1438); Low impedance (2285); Low Sensing Threshold (2575)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

This product is registered as a combination product.The results, method, and conclusion codes along with investigation results will be provided in the final report.

Event Description

During an in-clinic follow up, increase and decrease in pacing impedance, episodes of noise resulting in oversensing, and low sensing threshold was noted on the right ventricular (rv) lead.Technical support was contacted but the decrease in pacing impedance could not be confirmed.It was suspected that the cause of the event was due to rv lead insulation damage or a loose connection of the rv lead to the header of the device, however, no diagnostic imaging was conducted to confirm the supposition nor was the insulation damage visualized during the lead revision procedure.The rv lead was capped and replaced to resolve the event.The patient was stable with no consequences.

Manufacturer Narrative

The reported events were of insulation damage, loose connection of the rv lead to the header, high lead impedance, low lead impedance, low sensing, and noise resulting in oversensing.As received, a partial lead was returned in two pieces.The reported event of insulation damage was confirmed.Visual inspection found an external insulation abrasion breaching the ring electrode and non-functional cable lumens with intact ethylene tetrafluoroethylene cable coating at proximal region of the lead.The cause of insulation damage was due to external insulation abrasion which is consistent with friction to the device can.The reported event of high lead impedance, low sensing, noise resulting in oversensing were confirmed.Microscopic evaluation verified that all filars of the ring electrode coil were fractured distal to the connector ring.The cause of high lead impedance, noise resulting in oversensing was due to fractured ring electrode coil.The reported event of low lead impedance was not confirmed.Electrical testing did not find any indication of internal shorts.The impedance could not be tested due to the condition of the lead as received.Dimensional analysis of the connector pin, front seal, connector ring, and connector boot were all within specifications.The lead was able to insert and remove in a device without difficulty.Other damage found is consistent with procedural damage.

Event Description

During an in-clinic follow up, increase and decrease in pacing impedance, episodes of noise resulting in oversensing, and low sensing threshold was noted on the right ventricular (rv) lead.Technical support was contacted but the decrease in pacing impedance could not be confirmed.It was suspected that the cause of the event was due to rv lead insulation damage or a loose connection of the rv lead to the header of the device, however, no diagnostic imaging was conducted to confirm the supposition nor was the insulation damage visualized during the lead revision procedure.The rv lead was explanted replaced to resolve the event.The patient was stable with no consequences.

• Brand Name: DURATA STS OPTIM ACTIVE FIXATION
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ABBOTT; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10494814
• MDR Text Key: 205693945
• Report Number: 2938836-2020-08118
• Device Sequence Number: 1
• Product Code: LWS
• UDI-Device Identifier: 05414734502153
• UDI-Public: 05414734502153
• Combination Product (y/n): N
• PMA/PMN Number: P950022
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2012
• Device Model Number: 7122/65
• Device Catalogue Number: 7122-65
• Device Lot Number: 2995911
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 56 YR
• Patient Weight: 120