FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 1792445
·
Received August 11, 2010
Report
- Report Number
- 6000144-2010-03263
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- May 5, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- PHYSICIAN
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 POST-IMPLANT, THE PATIENT'S HEART RATE WAS 47-50 BPM AT TIMES. THE PACER IS PROGRAMMED TO 60-100 BPM. IT IS SUSPECTED TO BE IN MANAGED VENTRICULAR PACING MODE. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other | 4076 IMPLANTABLE PACING LEAD| 4592 IMPLANTABLE PACING LEAD |