FDA Adverse Event
Injury
Summary report: N
ATTAIN OTW
MDR report key: 2131296
·
Received June 16, 2011
Report
- Report Number
- 2649622-2011-10465
- Event Type
- Injury
- Date Received
- June 16, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P010015/S003
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD HAD HIGH IMPEDANCE IN SUPERIOR VENA CAVA (SVC) COIL. IT WAS CAPPED DURING THE EXPLANT, BECAUSE THE HELIX OF THE LEAD WOULD NOT RETRACT AFTER SEVERAL ATTEMPTS. A NEW LEAD WAS IMPLANTED. IT WAS ALSO REPORTED THAT THE LEFT VENTRICULAR LEAD HAD HIGH THRESHOLD AND DIAPHRAGM STIMULATION OCCURRED AT THRESHOLD IN ALL CONFIGURATIONS. THIS LEAD WAS CAPPED 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 |
|---|---|---|---|---|---|---|---|
| 1 | ATTAIN OTW | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4193 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR | Hospitalization| R | (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| (B)(4) IMPLANTABLE PACING LEAD |