FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 4162878
·
Received October 10, 2014
Report
- Report Number
- 3004209178-2014-19325
- Event Type
- Malfunction
- Date Received
- October 10, 2014
- Date of Event
- July 7, 2014
- Report Date
- July 7, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, 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: 407658 LEAD IMPLANTED: 2011 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A GASTRIC BYPASS PROCEDURE, THE PATIENT REPORTEDLY WENT INTO VENTRICULAR FIBRILLATION AND CHEST COMPRESSIONS WERE DONE. AN INTERROGATION DONE AFTER THE PROCEDURE DID NOT SHOW ANY VENTRICULAR HIGH RATE EPISODES. 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 |
|---|---|---|---|---|---|---|---|
| 639608 | ADAPTA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00063 YR | 5076-52 LEAD |