FDA Adverse Event
Malfunction
Summary report: N
ADAPTA DR
MDR report key: 5280429
·
Received December 9, 2015
Report
- Report Number
- 3004209178-2015-24237
- Event Type
- Malfunction
- Date Received
- December 9, 2015
- Report Date
- September 26, 2015
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- 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. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN BIKING, THE PATIENT'S DEVICE STOPS PACING AT 150 BEATS PER MINUTE (BPM) AND THE HEART RATE DROPS WITHIN A HALF A MINUTE TO 110-118 BPM. IT STAYS AT THIS RATE DURING EXERTION (IE. CLIMBING A HILL OR SPRINTING) AND THEN RISES TO AN EXPECTED LEVEL OF 130-140 BMP WHEN THE WORK DECLINES. THE PATIENT HAS MEASURED THIS PHENOMENON USING THREE SEPARATE MEASUREMENT SOURCES. 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 |
|---|---|---|---|---|---|---|---|
| 812730 | ADAPTA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC PUERTO RICO OPERATIONS CO. | ADDRL1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00070 YR |