FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN
MDR report key: 2880623
·
Received December 19, 2012
Report
- Report Number
- 3007566237-2012-03067
- Event Type
- Malfunction
- Date Received
- December 19, 2012
- Report Date
- November 19, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- DE, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID 8870, PRODUCT TYPE SOFTWARE. (B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL DEVICE: PRODUCT ID: 8840, SERIAL#: UNKNOWN, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED WHEN THE PHYSICIAN ATTEMPTED TO UPDATE THE PATIENT'S DOSE HE RECEIVED A PUMP MEMORY ERROR (PME) CODE THAT PUMP/CATHETER DATA WAS INVALID. IT WAS INDICATED THAT THE PHYSICIAN PROGRAMMER CARD WAS NOT UPDATED WITH THE LATEST VERSION. IT WAS NOTED THAT THE NEW UPDATED CARD WOULD BE ISSUED. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE OUTCOME WAS NOT PROVIDED. THE DRUG DELIVERED VIA PUMP WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |