FDA Adverse Event
Injury
Summary report: N
ATTAIN ABILITY
MDR report key: 2131096
·
Received June 16, 2011
Report
- Report Number
- 2649622-2011-10385
- Event Type
- Injury
- Date Received
- June 16, 2011
- 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
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD PAIN AT THE IMPLANT SITE AND THAT THE LEFT VENTRICULAR LEAD WAS CAUSING DIAPHRAGMATIC STIMULATION WHICH INCLUDED THE PATIENT'S SYMPTOM OF TWITCHING. THE PATIENT WAS TREATED WITH ORAL ACETAMINOPHEN FOR THEIR PAIN AND THE PATIENT'S LEFT VENTRICULAR LEAD WAS REPROGRAMMED TO RESOLVE THE DIAPHRAGMATIC STIMULATION. BOTH, THE DEVICE AND LEAD, ARE STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF 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 | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD| 5554 IMPLANTABLE PACING LEAD |