FDA Adverse Event
Injury
Summary report: N
ADAPTA
MDR report key: 3151928
·
Received June 7, 2013
Report
- Report Number
- 3004209178-2013-08804
- Event Type
- Injury
- Date Received
- June 7, 2013
- Report Date
- April 16, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
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 PRODUCTS: 4558M IMPLANTABLE PACING LEAD: (B)(6) 1997. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE RIGHT ATRIAL AND THE RIGHT VENTRICULAR LEADS BOTH HAD "SLIGHTLY HIGH THRESHOLDS." IT WAS FURTHER REPORTED THAT THE ATRIAL AND RIGHT VENTRICULAR LEADS CONTINUED TO EXHIBIT HIGH THRESHOLDS. THE LEADS WERE CAPPED AND REPLACED. ADDITIONALLY, THE DEVICE EXHIBITED UNEXPECTED LONGEVITY, AND WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 252345 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDR01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00068 YR | Hospitalization| R | 4024 IMPLANTABLE PACING LEAD |