FDA Adverse Event
Malfunction
Summary report: N
2017865-2008-01372
MDR report key: 1050386
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01372
- Event Type
- Malfunction
- Date Received
- May 27, 2008
- Date of Event
- February 1, 2008
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED TO THE CLINIC WITH ELEVATED VENTRICULAR THRESHOLDS OF GREATER THAN 6 V, 0.8 MS. VENTRICULAR CAPTURE WAS INTERMITTENT. THE PATIENT WAS NOT PACEMAKER DEPENDENT. THE PATIENT HAD BEEN UNDER- GOING DIALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DTB |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |