FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP
MDR report key: 2202952
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11582
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- May 18, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S12
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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 WAS NOT CAPTURING AT MAXIMUM OUTPUT. THE LEAD REMAINS 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 SP | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4024 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 90 YR | Other | 4524 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PULSE GENERATOR |