FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 1922045
·
Received December 13, 2010
Report
- Report Number
- 6000144-2010-05845
- Event Type
- Malfunction
- Date Received
- December 13, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P980035/S043
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. STUCK IN A SESSION. POSSIBLE REED SWITCH ISSUE.
Description of Event or Problem · 1
IT WAS REPORTED THAT CLINIC HAD TROUBLE GETTING MAGNET RATE FROM THE PATIENT THROUGH TRANS TELEPHONIC MONITORING (TTM). IT ALSO WAS FURTHER REPORTED THAT 2 MAGNETS HAD TO BE STACKED UP AND 'FIND PATIENT' FEATURE NEEDED TO BE USED TO INTERROGATE THE DEVICE. THE DEVICE IS STILL IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ADAPTA DR | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC MED REL, INC. | ADDRL1 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR | Other | (B)(4) IMPLANTABLE PACING LEADS |