FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY PLUS
MDR report key: 3153273
·
Received June 8, 2013
Report
- Report Number
- 2649622-2013-05909
- Event Type
- Injury
- Date Received
- June 8, 2013
- Date of Event
- March 5, 2013
- Report Date
- March 8, 2013
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCTS: D314TRG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD): (B)(6) 2013. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE PROXIMAL AND DISTAL CONDUCTORS OF THE LEAD AND THEY WERE NOT OBSTRUCTED.
Description of Event or Problem · 1
IT WAS REPORTED THE LEAD HAD ADVANCED OUT OF THE TARGET VESSEL BRANCH INTO ANOTHER BRANCH RESULTING IN NO CAPTURE. THE LEAD WAS REMOVED AND A NEW LEAD WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 256198 | ATTAIN ABILITY PLUS | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 429688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00077 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD |