FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP
MDR report key: 1922410
·
Received December 13, 2010
Report
- Report Number
- 2649622-2010-12915
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Date of Event
- May 14, 2010
- 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
- AL, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 THERE WAS A LEAD WARNING DUE TO LOW IMPEDANCES. IT WAS ALSO REPORTED THAT THE UNIPOLAR IMPEDANCE WAS HIGHER THAN BIPOLAR IMPEDANCE AND THE THRESHOLD INCREASED ON THE LEAD. THE LEAD IS STILL IN USE. NO PATIENT COMPLICATIONS WERE 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. | 4524 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Other | (B)(4) IMPLANTABLE PULSE GENERATOR| (B)(4) IMPLANTABLE PACING LEAD |