FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 1841863
·
Received September 21, 2010
Report
- Report Number
- 3007566237-2010-07157
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- August 1, 2010
- Report Date
- August 30, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD RECENT SPINAL SURGERY (NOT FURTHER SPECIFIED) AND IT WAS FOUND THAT THE CATHETER HAD DISLODGED. THE INTRATHECAL CATHETER HAD MIGRATED OUT OF THE INTRATHECAL SPACE; THIS WAS AN INCIDENTAL FINDING. IT WAS BELIEVED THAT THIS HAD OCCURRED SOME TIME AGO. THE HCP HAD BEEN CARING FOR THE PT FOR ONE YEAR AND HAD NO THERAPY ISSUES. THE HCP WAS REFILLING THE PUMP ON (B)(6) 2010 AND WAS CONCERNED REGARDING REFILLING THE PUMP WITH BACTERIOSTATIC SALINE OR DRUG. THE PUMP CONTAINED BACLOFEN. THE PT'S OUTCOME WAS NOT REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED; 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 | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | IMPLANTED:| CATHETER: MODEL 8709, LOT # N065828029| EXPLANTED: |