FDA Adverse Event
Malfunction
Summary report: N
ADAPTA SR
MDR report key: 3993259
·
Received August 8, 2014
Report
- Report Number
- 3008973940-2014-00311
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 12, 2014
- Report Date
- June 12, 2014
- Manufacturer
- MEDTRONIC SINGAPORE OPERATIONS
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- PHYSICIAN
Narratives
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
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE SET SCREW WAS FOUND IN THE CONNECTOR BORE.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT OF THE IMPLANTABLE PULSE GENERATOR (IPG) THERE WAS A DEVICE HEADER SCREW PROBLEM. THE DEVICE WAS NOT USED AND ANOTHER 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 |
|---|---|---|---|---|---|---|---|
| 469333 | ADAPTA SR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC SINGAPORE OPERATIONS | ADSR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR |