FDA Adverse Event
Injury
Summary report: N
SYNCHROMED INTRASPINAL CATHETER
MDR report key: 218043
·
Received April 6, 1999
Report
- Report Number
- 6000030-1999-00090
- Event Type
- Injury
- Date Received
- April 6, 1999
- Date of Event
- April 1, 1998
- Report Date
- March 9, 1999
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LKK
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- PATIENT
Narratives
Description of Event or Problem · 1
PT CALLED MFR 03/09/1999 AND STATED THAT A PIECE OF INTRASPINAL CATHETER REMAINED IN HER CSF. SHE IS SEEING ANOTHER PHYSICIAN WHO IS GOING TO REMOVE IT AT THE PT'S REQUEST. THE PT'S IMPLANTING PHYSICIAN STATED THAT THE PT HAS CALLED HIM AND NUMEROUS OTHER DRS SEEKING FINANCIAL COMPENSATION FOR INJURY. THE PT HAS NOT RETURNED TO THIS HCP FOR A PHYSICAL EXAMINATION. THE HCP THE PT STATED SHE IS NOW SEEING DID NOT RETURN TELEPHONE CALLS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHROMED INTRASPINAL CATHETER Implant | IMPLANTABLE INFUSION CATHETER | LKK | MEDTRONIC, INC. | 8703W | L41525 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Hospitalization | STATUS UNKNOWN.| SYNCHROMED INFUSION PUMP IMPLANTED 3/25/1997, |