FDA Adverse Event
Malfunction
Summary report: N
SECURA DR
MDR report key: 1854776
·
Received October 5, 2010
Report
- Report Number
- 6000144-2010-04410
- Event Type
- Malfunction
- Date Received
- October 5, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PATIENT
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 BY THE PATIENT'S SPOUSE THAT THE PATIENT'S HEART RATE IS IRREGULAR AND DROPS BELOW THE DEVICE'S MINIMUM PACING RATE OF 60 PPM, AS LOW AS IN THE 40'S AND EVEN THE UPPER 30'S BPM AT TIMES. SHE ALSO REPORTED THAT A NURSE MEASURED HIS PULSE AT 48 BPM. SHE WAS ASKING IF THE DEVICE WAS WORKING PROPERLY. THE DEVICE IS STILL IN USE. THERE WERE NO FURTHER PATIENT COMPLICATIONS 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 | 79 YR | Other | 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |