D
Patient 1
IT WAS REPORTED THAT THE VENTRICULAR LEAD EXHIBITED HIGH OUT OF RANGE IMPEDANCE AND LOSS OF SENSING. THE LEAD WAS NOT IMPLANTED AND PHYSICIAN ELECTS TO USE ANOTHER LEAD.
MAUDE MDR 4054465
- MDR report key
- 4054465
- Report number
- 2017865-2014-09008
- Event key
- 0
- Event type
- 3
- Date of event
- 2012-12-13
- Date received
- 2014-01-15
- 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
- CARY LAWLER
- Address
- 15900 VALLEY VIEW CT. SYLMAR CA 91342 US
- Phone
- 818-818-8184
- 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 STS | PERMANENT PACEMAKER ELECTRODE | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | DTS | 2088TC/58 | SMTFY999 | Y | Y |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-01-15 | 0 |
Event Narratives#
N
Patient 1
ALL INFO PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD. ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.