FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SENSE
MDR report key: 2203550
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11880
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 23, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S034
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, 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 DURING IMPLANT, THE PHYSICIAN HAD PROBLEMS POSITIONING THE RIGHT VENTRICULAR LEAD. THE PHYSICIAN COMPLAINED THAT THE LEAD WAS DEFECTIVE. HE WAS GOING TO TRY A NEW LEAD, BUT IT WAS DROPPED. THE PHYSICIAN THEN HAD THE FIRST LEAD IN A GOOD POSITION AND LEFT IT THERE. THE LEAD IS 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 | CAPSURE SENSE | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4074 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other |