FDA Adverse Event
Injury
Summary report: N
SENSIA DR
MDR report key: 4162468
·
Received October 10, 2014
Report
- Report Number
- 3008973940-2014-00431
- Event Type
- Injury
- Date Received
- October 10, 2014
- Date of Event
- May 9, 2014
- Report Date
- August 14, 2014
- Manufacturer
- MEDTRONIC SINGAPORE OPERATIONS
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. CONCOMITANT 5054-58 LEAD IMPLANTED: 2014-(B)(6). (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT REQUIRED A CARDIOVERSION FOLLOWING THE IMPLANT PROCEDURE. AFTER THE CARDIOVERSION, THE DEVICE EXHIBITED A LACK OF PACING AND NO INTERROGATION WAS POSSIBLE. THE DEVICE WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 639787 | SENSIA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC SINGAPORE OPERATIONS | SEDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Hospitalization| R | 407652 LEAD |