FDA Adverse Event
Injury
Summary report: N
ACTIVA
MDR report key: 5026115
·
Received August 24, 2015
Report
- Report Number
- 3004209178-2015-16540
- Event Type
- Injury
- Date Received
- August 24, 2015
- Date of Event
- July 29, 2015
- Report Date
- July 30, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V902308, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6)2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V688050, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).
Description of Event or Problem · 1
A HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2015 THERE WAS AN INFECTION AT THE STIMLOCK AND ON (B)(6) 2015 THERE WAS AN EXPLANT. IT WAS UNKNOWN WHAT HAD LED TO THE EVENT. A CULTURE WAS TAKEN. THE ISSUE WAS RESOLVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559427 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37603 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00072 YR | Required Intervention |