FDA Adverse Event
Injury
Summary report: N
PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
MDR report key: 3140667
·
Received May 31, 2013
Report
- Report Number
- 3007566237-2013-01822
- Event Type
- Injury
- Date Received
- May 31, 2013
- Report Date
- May 7, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8711, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER: PRODUCT ID 8709, SERIAL# UNKNOWN. PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A ROUTINE PUMP REPLACEMENT FOR END OF BATTERY LIFE THE CATHETER WAS NOTICED TO BE FRACTURED AND PARTIALLY DISCONNECTED FROM THE PUMP. THE CATHETER WAS REPLACED. THERE WERE NO SYMPTOMS REPORTED. THE MEDICATION DELIVERED BY THE INFUSION SYSTEM WAS NOT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 241768 | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |