FDA Adverse Event
Malfunction
Summary report: N
ASSURITY RF DR
MDR report key: 6130680
·
Received November 28, 2016
Report
- Report Number
- 2938836-2016-14938
- Event Type
- Malfunction
- Date Received
- November 28, 2016
- Date of Event
- October 31, 2016
- Report Date
- October 31, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- LWP
- PMA / PMN Number
- P970013
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING REGULAR FOLLOW-UP, INAPPROPRIATE AUTO MODE SWITCHING DUE TO FAR P-WAVE OVERSENSING WAS OBSERVED. THERE WERE TOO MANY MODE SWITCHES THAT DID NOT HAVE AN EGM THAT SUGGESTED ACTUAL ATRIAL ARRHYTHMIA (AT,AF,OR AFL). PROGRAMMING CHANGES WERE MADE. PATIENT WAS FINE DURING FOLLOW-UP AND HAD NO SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 780965 | ASSURITY RF DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | LWP | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | PM2240 | A000001858 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |