FDA Adverse Event
Injury
Summary report: N
ATTAIN STARFIX OTW
MDR report key: 2964411
·
Received February 15, 2013
Report
- Report Number
- 2649622-2013-02109
- Event Type
- Injury
- Date Received
- February 15, 2013
- Date of Event
- March 27, 2012
- Report Date
- December 10, 2012
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P060039
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AK, US
- Reporter Occupation
- PHYSICIAN
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. (B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT COMPLAINED OF "MUSCLE CRAMPS IN THE CHEST AREA WHILE SLEEPING". THE LEFT VENTRICULAR (LV) LEAD AMPLITUDE WAS DECREASED. THE LEAD IS STILL IN USE. THE PATIENT IS ENROLLED IN THE SYSTEMS LONGEVITY STUDY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Description of Event or Problem · 1
IT WAS ALSO REPORTED THAT THE LEAD THRESHOLD INCREASED WITH INTERMITTENT CAPTURE ONLY. THE LEAD WAS INACTIVATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 66981 | ATTAIN STARFIX OTW | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR | Required Intervention |