FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP
MDR report key: 2202882
·
Received August 11, 2011
Report
- Report Number
- 2649622-2011-11562
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Date of Event
- January 1, 2009
- 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
- MI, 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 THE BIPOLAR IMPEDANCE HAS DECREASED OVER THE PAST TWO YEARS. THE UNIPOLAR IMPEDANCE IS NOW GREATER THAN THE BIPOLAR IMPEDANCE. THE LEAD REMAINS IN USE AND WILL CONTINUE TO BE MONITORED. 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. | 4024 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 91 YR | Other | SSR303 IMPLANTABLE PULSE GENERATOR| (B)(4) TISSUE VALVE| (B)(4) TISSUE VALVE |