FDA Adverse Event
Malfunction
Summary report: N
CAPSURE SP
MDR report key: 2810852
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16315
- Event Type
- Malfunction
- Date Received
- October 31, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P830061/S12
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, 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 PATIENT HAS FALLEN COUPLE OF TIMES LATELY. IT WAS ALSO REPORTED THAT THE PATIENT HAD A HISTORY OF FAR FIELD R WAVE OVERSENSING. FOLLOW UP INDICATED THE PATIENT HAS OTHER HEALTH ISSUES UNRELATED TO THE PATIENT'S DEVICE OR LEAD AND THE ISSUE OF FALLING HAS BEEN "ONGOING". 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. | 4524 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Other | (B)(4) IMPLANTABLE PULSE GENERATOR| 5026 IMPLANTABLE PACING LEAD |