FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 1922547
·
Received December 13, 2010
Report
- Report Number
- 2649622-2010-12999
- Event Type
- Injury
- Date Received
- December 13, 2010
- Date of Event
- September 2, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- OJX
- PMA / PMN Number
- P080006
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES WERE FOUND; HOWEVER, BLOOD/BODY FLUID WAS FOUND ON ALL CONDUCTORS AT THE DISTAL END (NOT OBSTRUCTED), AND ON THE DISTAL CONDUCTOR AT THE TIP TO RING SAPCER (NOT OBSTRUCTED). THE LEAD WAS STRETCHED AND APPARENT EXPLANT DAMAGE WAS NOTED. THE FULL LEAD WAS RETURNED AND ANALYZED.
Description of Event or Problem · 1
IT WAS REPORTED THAT STIMULATION OF THE DIAPHRAGM WAS OBSERVED. THE LEFT VENTRICULAR LEAD WAS REMOVED AND RETURNED. A NEW LEAD WAS PLACED IN A DIFFERENT BRANCH OF THE CORONARY VENOUS VASCULATURE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN ABILITY | IMPLANTABLE PACING LEAD | OJX | MEDTRONIC PUERTO RICO, INC. | 4196 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6935 IMPLANTABLE TACHY LEAD |