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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC EUROPE SARL VIVA CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)

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MEDTRONIC EUROPE SARL VIVA CRT-P PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P) Back to Search Results
Model Number C6TR01
Device Problems Signal Artifact/Noise (1036); Premature Discharge of Battery (1057); Electromagnetic Interference (1194); Over-Sensing (1438)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/23/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the right ventricular (rv) lead exhibited a high lead impedance warning. A polarity switch occurred. The lead also exhibited high number of the sensing integrity counter (sic) oversensing episodes and noise. The patient is pacemaker dependent and is symptomatic to noise on the rv lead, which is causing underpacing. Rv lead fracture was suspected. The rv lead was removed and replaced with a rv his bundle lead. It was further reported that the symptoms the patient experienced was intermittent dizziness and presyncope. During the rv lead replacement procedure, the left ventricular (lv) lead was inadvertently cut with scissors as the scar tissue was being removed. The physician tried to remove the entire lv lead and attempted to place another lv lead, however, the lateral branch was occluded. The lv lead was partially removed. It was further reported that the cardiac resynchronization therapy pacemaker (crt-p) exhibited noise on the atrial channel due to cautery during the rv lead revision. The crt-p remains in use. No further patient complications have been reported as a result of this event.
 
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Brand NameVIVA CRT-P
Type of DevicePULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION (CRT-P)
Manufacturer (Section D)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer (Section G)
MEDTRONIC EUROPE SARL
route du molliau 31
case postale
tolochenaz vaud 1131
CH 1131
Manufacturer Contact
paula bixby
8200 coral sea st ne
mounds view, MN 55112
7635055378
MDR Report Key10645107
MDR Text Key210311375
Report Number9614453-2020-03150
Device Sequence Number1
Product Code NKE
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Model NumberC6TR01
Device Catalogue NumberC6TR01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/30/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/07/2020 Patient Sequence Number: 1
Treatment
5076-58 LEAD, 439688 LEAD, 5076-52 LEAD
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