FDA Adverse Event
Injury
Summary report: N
SYNCRHOMED II
MDR report key: 1822614
·
Received August 27, 2010
Report
- Report Number
- 3004209178-2010-06525
- Event Type
- Injury
- Date Received
- August 27, 2010
- Date of Event
- July 26, 2010
- Report Date
- December 28, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LKK
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF PAIN CONTROL AND WITHDRAWAL SYMPTOMS. THE PUMP WAS INTERROGATED AS PART TO THE TROUBLESHOOTING PROCESSED AND DETERMINED TO BE FUNCTIONING NORMALLY. THE PATIENT UNDERWENT A SURGICAL REVISION ON (B)(6)2010, THE CATHETER WAS SPLICED. THE SPINAL SEGMENT OF THE CATHETER WAS REPLACED. THE TIP OF THE CATHETER WAS MOVED FROM T5 TO T7 IN EFFORT TO REGAIN PAIN CONTROL. THE PATIENT RECOVERED WITHOUT SEQUELA. THE PUMP CONTAINED A MIXTURE OF DILAUDID (25MG/ML, 10.507MCG/DAY), BUPIVACAINE (20MG/ML), 8.406MG/DAY), AND BACLOFEN (150MCG/ML, 63.04MCG/DAY AT THE TIME OF THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCRHOMED II | LKK | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 863720 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Female | Required Intervention | CATHETER: MODEL 8703W, LOT# L45811.| EXPLANTED:| IMPLANTED:| IMPLANTED:| CATHETER: MODEL 8703W, LOT# L45811| EXPLANTED: |