FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 1922108
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-05856
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- 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 ON THE CARELINK REPORT, THE PACEMAKER'S VENTRICULAR ELECTROGRAM (EGM) SIGNAL LOOKS JUST LIKE THE ATRIAL EGM SIGNAL. THE DEVICE 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 DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other | (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD |