FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED
MDR report key: 4132575
·
Received October 1, 2014
Report
- Report Number
- 3007566237-2014-02790
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Report Date
- September 9, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_CATH, SERIAL# UNKNOWN, PRODUCT TYPE: CATHETER. (B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING THE PUMP REPLACEMENT PROCEDURE FOR ROUTINE BATTERY REPLACEMENT, RUBBER-TIPPED FORCEPS WERE USED TOO FORCIBLY/AGGRESSIVELY RESULTING IN THE NEED TO REPLACE THE ENTIRE CATHETER. THE PATIENT/DEVICE INFORMATION, SYMPTOMS, OUTCOME, AND DRUG IN THE PUMP AT THE TIME OF THE EVENT WERE NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 611403 | SYNCHROMED | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_PUMP |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |