FDA Adverse Event
Injury
Summary report: N
ATTAIN PERFORMA
MDR report key: 6164782
·
Received December 9, 2016
Report
- Report Number
- 2649622-2016-16314
- Event Type
- Injury
- Date Received
- December 9, 2016
- Date of Event
- October 31, 2016
- Report Date
- October 31, 2016
- Manufacturer
- MPRI
- Product Code
- OJX
- UDI-DI
- 00643169169081
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: 6947M62 LEAD, IMPLANTED: (B)(6) 2015; DTBB1QQ CRTD, IMPLANTED: (B)(6) 2015.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S RIGHT ATRIAL (RA) LEAD EXHIBITED LOW IMPEDANCE. THE RA LEAD WAS EXPLANTED AND REPLACED. IT WAS ALSO REPORTED THAT THE PATIENT'S LEFT VENTRICULAR (LV) LEAD DISLODGED. THE LV LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 813753 | ATTAIN PERFORMA | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 459888 | 00643169169081 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Hospitalization| R | 5024M-52 LEAD, 4524-45 LEAD |