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

Model Number 5554-53

Device Problem Connection Problem (2900)

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

Event Date 04/02/2021

Event Type  Injury  

Manufacturer Narrative

Concomitant products: dtpa2d1 crt-d implanted: (b)(6) 2021.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that after a generator changeout procedure, it was noted that the current waveform on the electrograms (egm) was different than the waveform observed before the procedure.The pocket was re-opened and it was confirmed that the right atrial (ra) lead and left ventricular (lv) lead had been reversed in the device connector.The ra and lv lead were re-connected in the correct ports and remain in use.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: 11731930
• MDR Text Key: 247503656
• Report Number: 2649622-2021-08422
• 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: 04/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/27/2013
• Device Model Number: 5554-53
• Device Catalogue Number: 5554-53
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2021
• Date Device Manufactured: 02/10/2011
• 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
• Treatment: 694765 LEAD, 419488 LEAD
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 74 YR