FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2187148
·
Received June 7, 2011
Report
- Report Number
- 3007566237-2011-04106
- Event Type
- Malfunction
- Date Received
- June 7, 2011
- Date of Event
- May 1, 2011
- Report Date
- May 10, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED ACUTE PAIN. THE PT'S PHYSICIAN THOUGHT THERE WAS AN ISSUE WITH THE PUMP. THERE WERE TWO DATES STATING THE LONGEVITY OF THE PUMP AND THERE WAS TOO MUCH MEDICATION IN THE PUMP. THE PT WAS GOING BACK TO THE DOCTOR TO DETERMINE THE NEXT STEPS. ADDITIONAL INFO HAS BEEN REQUESTED, A F/U 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 | 62 YR | IMPLANTED:| CATHETER: MODEL 8703W, LOT# L51670| EXPLANTED: |