FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 3140584
·
Received May 31, 2013
Report
- Report Number
- 3007566237-2013-01819
- Event Type
- Injury
- Date Received
- May 31, 2013
- Report Date
- May 10, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: CATHETER: PRODUCT ID 8709, SERIAL# (B)(4), IMPLANTED: (B)(6) 2004. PRODUCT TYPE: CATHETER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD THEIR DEVICE SYSTEM REMOVED DUE TO IT ¿NO LONGER WORKING¿ RELATED TO A HEALTH CARE PROVIDER ¿PUTTING IN THE WRONG TUBING¿ WHICH CAUSED A ¿CRACK¿ AND SUBSEQUENT EXPLANT. THE MEDICATION BEING DELIVERED VIA THE DEVICE SYSTEM WAS UNKNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 240886 | SYNCHROMED II | PUMP, INFUSION, IMPLANTED, PROGRAMMABLE | LKK | MEDTRONIC NEUROMODULATION | 863740 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |