MAUDE Adverse Event Report: MPRI ATTAIN BIPOLAR OVER THE WIRE LEAD; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)

Model Number 419478

Device Problems High Capture Threshold (3266); Unstable Capture Threshold (3269)

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

Event Date 05/18/2022

Event Type  malfunction  

Event Description

It was reported that the right ventricular (rv) lead exhibited high undefined pacing impedance, intermittent noise, oversensing, and short ventricular intervals.An increase in non-sustained ventricular tachycardia episodes and premature ventricular contractions were noted to likely be noise, not true arrhythmias.It was also reported that the left ventricular (lv) lead exhibited variable pacing thresholds that were possibly high.The leads remain in use.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Concomitant medical products: c4tr01, crt-p; implanted (b)(6) 2014.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ATTAIN BIPOLAR OVER THE WIRE LEAD
• Type of Device: IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
• 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: 14624987
• MDR Text Key: 293535571
• Report Number: 2649622-2022-10956
• Device Sequence Number: 1
• Product Code: LWP
• UDI-Device Identifier: 00885074113364
• UDI-Public: 00885074113364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/21/2009
• Device Model Number: 419478
• Device Catalogue Number: 419478
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/07/2022
• 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: 5076-52 LEAD, 694765 LEAD.
• Patient Age: 65 YR
• Patient Sex: Male