FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 3990948
·
Received August 8, 2014
Report
- Report Number
- 2649622-2014-08395
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 22, 2014
- Report Date
- June 26, 2014
- Manufacturer
- MPRI
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, 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. PRODUCTS: 6935M-55 IMPLANTABLE TACHY LEAD IMPLANTED: 2014 (B)(6); 5076-45 IMPLANTABLE PACING LEAD IMPLANTED 2012 (B)(6). (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
.
Description of Event or Problem · 1
IT WAS REPORTED THE RIGHT AND LEFT VENTRICULAR LEADS HAD DISLODGED OR "PULLED BACK". THE LEADS WERE REMOVED 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 |
|---|---|---|---|---|---|---|---|
| 470495 | ATTAIN ABILITY | DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE | OJX | MPRI | 419688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00066 YR | Hospitalization| R | (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (IC |