FDA Adverse Event
Injury
Summary report: N
CAPSURE SP
MDR report key: 2811371
·
Received October 31, 2012
Report
- Report Number
- 2649622-2012-16840
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- September 28, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- P850089/S6
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SE
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT VENTRICULAR WAS ACCIDENTLY CUT-OFF DURING A REPLACEMENT PROCEDURE FOR NORMAL BATTERY DEPLETION. THE LEAD WAS SURGICALLY ABANDONED AND WAS REPLACED WITH A NEW LEAD. THE PATIENT IS A PARTICIPANT IN THE SHOCK-LESS STUDY (SLS). 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. | 5023 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | (B)(4) IMPLANTABLE PULSE GENERATOR |