FDA Adverse Event
Malfunction
Summary report: N
ADAPTA SR
MDR report key: 3160493
·
Received June 10, 2013
Report
- Report Number
- 9614453-2013-01426
- Event Type
- Malfunction
- Date Received
- June 10, 2013
- Report Date
- April 5, 2013
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS REVEALED ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT "DUE TO COLD STORAGE DEVICE COULD NOT BE INTERROGATED AND IMPLANTED." IT WAS FURTHER REPORTED THAT WHEN INTERRO GATING THE DEVICE IN A WARM SURROUNDING PRIOR TO IMPLANT, INTERROGATION WORKED HOWEVER, SHOWED A VOLTAGE OF 2.72 VOLTS AND THE INFORMATION "REPLACE PACER". THE DEVICE WAS NOT IMPLANTED. THERE WAS NO PATIENT INVOLVEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259726 | ADAPTA SR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | IPG MFG SWITZERLAND | ADSR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |