FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 4160208
·
Received October 10, 2014
Report
- Report Number
- 3004209178-2014-19139
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 16, 2014
- Report Date
- July 16, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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. PRODUCTS: 407645 LEAD IMPLANTED 2014 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S HEART RATE HAS INCREASED "MORE THAN FOURFOLD" WHEN WORKING IN A PARTICULAR LOCATION IN THE PATIENT'S LAB. THE PATIENT SUSPECTED ELECTROMAGNETIC INTERFERENCE (EMI) FROM THE LAB EQUIPMENT. THE PATIENT'S IMPLANTABLE PULSE GENERATOR (IPG) 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 |
|---|---|---|---|---|---|---|---|
| 638443 | ADAPTA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00074 YR | 407652 LEAD |