MAUDE Adverse Event Report: MPRI CAPSUREFIX NOVUS; ELECTRODE, PACEMAKER, PERMANENT

Model Number 5076-58

Device Problems Retraction Problem (1536); Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

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

Event Date 06/27/2018

Event Type  malfunction  

Manufacturer Narrative

2649622-2018-11632 if information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that tortuous venous anatomy was making right ventricular (rv) lead insertion difficult.The physician removed the l ead to evaluate its integrity.The helix did not extend or retract smoothly and the physician was concerned that the lead had become damaged through the difficult insertion process.A different lead was ultimately implanted.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the full lead was returned and analyzed and the proximal conductor of the lead became extrinsically distorted due to kinking/buckling.Visual analysis of the lead indicated damage at implant.The analyst noted helix testing is not possible due to the kinked proximal conductor placing pressure on the distal conductor and causing the helix to jump in and out of the sleeve.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CAPSUREFIX NOVUS
• Type of Device: ELECTRODE, PACEMAKER, PERMANENT
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7695335
• MDR Text Key: 114587732
• Report Number: 2649622-2018-11632
• Device Sequence Number: 1
• Product Code: DTB
• UDI-Device Identifier: 00643169633766
• UDI-Public: 00643169633766
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P930039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2020
• Device Model Number: 5076-58
• Device Catalogue Number: 5076-58
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2018
• 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
• Patient Age: 87 YR
• Patient Weight: 61