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

Model Number 503458

Device Problems Failure to Capture (1081); High impedance (1291); Over-Sensing (1438); Connection Problem (2900); Impedance Problem (2950); High Capture Threshold (3266)

Patient Problems Bradycardia (1751); Dizziness (2194)

Event Date 10/20/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the patient experienced dizziness and heart rate in the forties.It was reported that a right ventricular (rv) lead exhibited non capture, high thresholds, high impedance and oversensing approximately two days post implant of a new implantable pulse generator (ipg).The rv lead was reprogrammed.It was reported that the lead pin pulled out of header of the newly implanted ipg without unscrewing the setscrew.The lead connection was revised.No further patient complications have been reported as a result of this event.

• Brand Name: CAPSURE Z
• Type of Device: PERMANENT PACEMAKER ELECTRODE
• 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: 12786129
• MDR Text Key: 280570238
• Report Number: 2649622-2021-22403
• Device Sequence Number: 1
• Product Code: DTB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P850089
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/23/2001
• Device Model Number: 503458
• Device Catalogue Number: 503458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2021
• 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: W1SR01 IPG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 95 YR
• Patient Sex: Male
• Patient Weight: 82 KG