FDA.reportPublic FDA data

MAUDE MDR 9908660

MDR report key
9908660
Report number
2938836-2020-02373
Event key
0
Event type
3
Date of event
2020-02-26
Date received
2020-03-31
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
ELIZABETH BOLTZ
Address
15900 VALLEY VIEW COURT SYLMAR CA 91342 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1TENDRIL STSPERMANENT PACEMAKER ELECTRODEST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)NVN2088TC/462088TC-46A000073402R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-310

Event Narratives#

N

Patient 1

THIS PRODUCT IS REGISTERED AS A COMBINATION PRODUCT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

D

Patient 1

RELATED MANUFACTURER REFERENCE NUMBER: 2938836-2020-02374; 2938836-2020-02375. IT WAS REPORTED THAT DURING IN CLINIC CHECK, LOW IMPEDANCE WAS OBSERVED ON THE RIGHT ATRIAL AND VENTRICULAR LEADS. THE PHYSICIAN ALSO ALLEGED MALFUNCTION ON THE PACEMAKER. THE NOISE WAS NOT REPRODUCIBLE BUT CURRENTLY, THE CLINIC STILL RECEIVED IMPEDANCE ALERTS ON MERLIN.NET. THE PATIENT WAS STABLE AND WILL CONTINUE TO BE MONITORED SINCE HE WAS NOT PACEMAKER DEPENDENT.