MAUDE Adverse Event Report: MPRI CAPSURE Z NOVUS LEAD; ELECTRODE, PACEMAKER, PERMANENT

Model Number 5054-52

Device Problems High impedance (1291); Connection Problem (2900); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/03/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, during generator changeout procedure, while suturing the pocket, the right ventricular (rv) lead was, "barely moved at the time of suturing," but the physician was not informed at that time and the pocket was closed.Post pocket closure device check, showed a right ventricular (rv) lead high and undefined bipolar lead impedance, with unchanged unipolar impedance.X-ray revealed that the right ventricular (rv) lead was not connected fully to the rv port.Re-operation was performed and the rv lead was re-connected to the rv port, with good measured values and both the rv lead and the implantable pulse generator (ipg) remain in use.A reported possible additional cause of the disconnection included lack of slack on the rv lead, creating pressure while torque was being applied.No patient complications have been reported as a result of this event.

• Brand Name: CAPSURE Z NOVUS LEAD
• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 11701965
• MDR Text Key: 246555994
• Report Number: 2649622-2021-07960
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P850089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2009
• Device Model Number: 5054-52
• Device Catalogue Number: 5054-52
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2021
• Date Device Manufactured: 04/17/2007
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 86 YR