FDA Adverse Event
Malfunction
Summary report: N
ADAPTA SR
MDR report key: 1854929
·
Received October 5, 2010
Report
- Report Number
- 6000144-2010-04344
- Event Type
- Malfunction
- Date Received
- October 5, 2010
- Date of Event
- August 13, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT VENTRICULAR CAPTURE MANAGEMENT (VCM) IS SHOWING HIGH THRESHOLDS WHILE IN-OFFICE REVEALS 1.5V AT .40 MS USING SURFACE ECG. THE LEAD REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA SR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADSR06 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | UNKNOWN IMPLANTABLE PACING LEAD |