FDA Adverse Event
Injury
Summary report: N
ACTIVA
MDR report key: 2921872
·
Received January 18, 2013
Report
- Report Number
- 3004209178-2013-00746
- Event Type
- Injury
- Date Received
- January 18, 2013
- Report Date
- December 28, 2012
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 3708660, SERIAL #(B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # VA0224T, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS HEALING WELL WITHOUT COMPLICATIONS. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN REIMPLANTED. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD HER RIGHT IMPLANTABLE NEUROSTIMULATOR (INS), EXTENSION AND LEAD REMOVED DUE TO AN INFECTION. THE NATURE OF THE INFECTION WAS UNKNOWN TO THE REPORTER AT THE TIME OF THE REPORT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 28527 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |