FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE PUMP
MDR report key: 4161996
·
Received October 10, 2014
Report
- Report Number
- 3007566237-2014-02915
- Event Type
- Injury
- Date Received
- October 10, 2014
- Report Date
- September 15, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID: NEU_UNKNOWN_CATH, : PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT HAD THEIR PUMP REPLACED AFTER IT WENT EMPTY. THEY HAD MISSED A REFILL WHILE ON A TRIP. NO FURTHER INFORMATION WAS PROVIDING INCLUDING PATIENT OR DEVICE INFORMATION, SYMPTOMS, IF ANY TROUBLESHOOTING OR OTHER ACTIONS WERE TAKEN OR PATIENT OUTCOME. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 643793 | UNKNOWN IMPLANTABLE PUMP | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |