• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MPRI ATTAIN BIPOLAR OVER THE WIRE LEAD; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key14624987
MDR Text Key293535571
Report Number2649622-2022-10956
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00885074113364
UDI-Public00885074113364
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010015
Number of Events Reported1
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 Date04/21/2009
Device Model Number419478
Device Catalogue Number419478
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/18/2022
Initial Date FDA Received06/07/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
5076-52 LEAD, 694765 LEAD.
Patient Age65 YR
Patient SexMale
-
-