N
Patient 1
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.
MAUDE MDR 9908832
- MDR report key
- 9908832
- Report number
- 2017865-2020-03573
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-03-11
- 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 | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | TENDRIL ST | PERMANENT PACEMAKER ELECTRODE | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) | NVN | 1888TC/52 | 1888TC-52 | 2853709 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-31 | 0 | 1. R |
Event Narratives#
D
Patient 1
RELATED MANUFACTURER REFERENCE NUMBER- 2017865-2020-03574. RELATED MANUFACTURER REFERENCE NUMBER- 2017865-2020-04152. IT WAS REPORTED THAT THE PACER DEPENDENT PATIENT PRESENTED IN CLINIC FOR FOLLOW-UP. UPON INTERROGATION, THE RIGHT ATRIAL LEAD EXHIBITED NOISE. IT WAS ALSO NOTED THAT THE RIGHT VENTRICULAR LEAD EXHIBITED LOW SENSING AND OVERSENSING RESULTING IN INHIBITION. THE LEADS WERE NOTED TO BE FRACTURED. THE PATIENT WAS IN STABLE CONDITION. ON (B)(6) 2020, THE LEADS WERE CAPPED AND REPLACED. DURING THE PROCEDURE, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS ALSO EXPLANTED AND REPLACED DUE TO AN UNSPECIFIED REASON.