FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE PUMP
MDR report key: 3150732
·
Received June 6, 2013
Report
- Report Number
- 3007566237-2013-01883
- Event Type
- Injury
- Date Received
- June 6, 2013
- Report Date
- May 10, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1060-2011, Z-3043-2011
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A SUBJECT ON (B)(6) HAD WRITTEN SHE HAD A POCKET FILL BUT WAS ¿OK¿. IT WAS LATER REPORTED THAT IT WAS AN OLD POCKET REFILL FROM ¿(B)(6)¿; THAT THE PATIENT WAS IN THE HOSPITAL. IT WAS LATER REPORTED THAT A COORDINATOR HAD MENTIONED IN (B)(6) THAT THERE WAS A (B)(6) STATUS UPDATE PAGE TALKING ABOUT A POCKET FILL REACTION AND HOSPITALIZATION. PER THE COORDINATOR, IT DID NOT HAPPEN AT THEIR SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 250971 | UNKNOWN IMPLANTABLE PUMP | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization |