FDA Adverse Event
Malfunction
Summary report: N
SENSIA
MDR report key: 3151834
·
Received June 7, 2013
Report
- Report Number
- 9614453-2013-01085
- Event Type
- Malfunction
- Date Received
- June 7, 2013
- Date of Event
- March 7, 2013
- Report Date
- March 7, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SF
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
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. (B)(4).
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY - THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND. THE RETURNED DEVICE INDICATED A DAMAGED GROMMET AND FOREIGN MATERIAL ON SET SCREW.
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 PRIOR TO IMPLANT THE SCREW THAT IS USED TO HOLD THE LEAD IN PLACE WAS LOOSE IN THE SEALED BOX. THE DEVICE WAS NOT USED AND A NEW DEVICE WAS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252746 | SENSIA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | SEDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |