FDA Adverse Event
Injury
Summary report: N
ADAPTA DR
MDR report key: 3051587
·
Received April 10, 2013
Report
- Report Number
- 3004209178-2013-05970
- Event Type
- Injury
- Date Received
- April 10, 2013
- Report Date
- February 27, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- PMA / PMN Number
- P980035
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 : 5092 IMPLANTABLE PACING LEAD: (B)(6) 2003. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
PRODUCT EVENT SUMMARY : THE DEVICE WAS RETURNED AND ANALYZED WITH NO ANOMALIES FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS A BACTEREMIA INFECTION THAT LED TO THE EROSION OF THE POCKET. THE SYSTEM WAS EXPLANTED AND LATER REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152030 | ADAPTA DR | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDRS1 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00094 YR | Hospitalization| R | ADDRS1 IMPLANTABLE PACEMAKER |