FDA Adverse Event
Injury
Summary report: N
SYNCHROMED II
MDR report key: 1060652
·
Received June 13, 2008
Report
- Report Number
- 2182207-2008-03219
- Event Type
- Injury
- Date Received
- June 13, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 15, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Removal / Correction Number
- Z-1151-2008
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CATHETER.
Description of Event or Problem · 1
THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT FOLLOWING A PUMP AND CATHETER REPLACEMENT. AN INFLAMMATORY MASS WAS REPORTED. THE PT WAS ADMITTED TO THE HOSPITAL. THE PATIENT'S STATUS WAS REPORTED AS "FAIR". THE PT WAS ENCOURAGED TO CONTACT HIS HCP. THE TYPE OF MEDICATION, CONCENTRATION, AND DAILY DOSE BEING ADMINISTERED VIA THE PUMP WERE NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED II | LKK | MEDTRONIC NEUROMODULATION | 863740 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | PROGRAMMER MODEL 8840 LOT # UNK| CATHETER MODEL 8709 LOT# N144191021 IMPLANTED| EXPLANTED |