FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 1863084
·
Received October 9, 2010
Report
- Report Number
- 6000144-2010-04999
- Event Type
- Malfunction
- Date Received
- October 9, 2010
- Date of Event
- July 8, 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
- OH, US
- Reporter Occupation
- NURSE
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 A POLARITY SWITCH HAD OCCURRED ON THE VENTRICULAR LEAD, POSSIBLY DUE TO EMI (ELECTROMAGNETIC INTERFERENCE) FROM SECURITY WAND SCREENING. HIGH IMPEDANCE PACES ALSO REPORTED. 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 | 86 YR | Other | 1388T 2X (COMP) IMPLANTABLE PACING LEAD |