FDA Adverse Event
Malfunction
Summary report: N
ATTAIN STARFIX
MDR report key: 4834062
·
Received June 10, 2015
Report
- Report Number
- 2649622-2015-06749
- Event Type
- Malfunction
- Date Received
- June 10, 2015
- Date of Event
- April 8, 2015
- Report Date
- April 8, 2015
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P060039
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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). EVALUATION SUMMARY: THE OVERLAY TUBING OF THE LEAD WAS OBSERVED TO HAVE BLOOD INGRESSION; FULL LEAD RETURNED AND ANALYZED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT OF THE LEFT VENTRICULAR (LV) LEAD THE LOBES WOULD NOT EXTEND PROPERLY. THE LEAD WAS NOT USED AND REPLACED WITH ANOTHER LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 380340 | ATTAIN STARFIX | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00089 YR | P1501DR IPG, 5076-45 LEAD, 5076-52 LEAD |