FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 3993091
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14697
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- May 1, 2011
- Report Date
- June 20, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
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) 2005. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD PACEMAKER SYNDROME. THE DEVICE REMAINS IN USE, AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 468413 | ADAPTA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | 5076-45 LEAD |