FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 3992448
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14830
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- June 25, 2014
- Report Date
- June 25, 2014
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- 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. CONCOMITANT MEDICAL PRODUCT: 4592-53 LEAD, IMPLANTED: (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WENT TO THE EMERGENCY ROOM AND WAS FEELING DIZZY. RATE DROP RESPONSE DETAIL WAS TURNED ON, THE DROP SIZE WAS ADJUSTED, AND 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 |
|---|---|---|---|---|---|---|---|
| 468469 | ADAPTA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC PUERTO RICO OPERATIONS CO. | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00076 YR | Required Intervention | 4092-58 LEAD |