FDA Adverse Event
Malfunction
Summary report: N
SECURA DR
MDR report key: 1925015
·
Received December 14, 2010
Report
- Report Number
- 6000144-2010-06184
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- September 22, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- 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 EPISODES SHOW VARYING AMPLITUDES OF R WAVES AND P WAVES WITH OVERSENSING AND DOUBLE COUNTING OF R WAVES AND SOME VERY FAST RATES ARRYTHMIAS. DEVICE IS STILL 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 | SECURA DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D224DRG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Other | 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |