FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 3992854
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14739
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 27, 2014
- Report Date
- June 27, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- NURSE
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. CONCOMITANT MEDICAL PRODUCTS: 5076-52 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WITHIN A FEW WEEKS OF IMPLANT, 64 ATRIAL HIGH RATE AND 3 VENTRICULAR HIGH RATE EPISODES (NOISE/ELECTROCAUTERY) WERE NOTED. IT WAS ALSO REPORTED THAT THERE WERE INDECIPHERABLE DUAL ELECTROGRAMS FOUND ON THE DEVICE REPORT/INTERROGATION/TRANSMISSION. THE DEVICE REMAINS 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 |
|---|---|---|---|---|---|---|---|
| 471242 | ADAPTA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00079 YR | 5076-58 LEAD |