FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2322640
·
Received October 13, 2011
Report
- Report Number
- 3007566237-2011-08874
- Event Type
- Malfunction
- Date Received
- October 13, 2011
- Date of Event
- September 15, 2011
- Report Date
- October 12, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). FINAL ANALYSIS OF THE PUMP REVEALED BATTERY RESISTANCE HIGH. PER ANALYSIS. "IN HOUSE BATTERY TESTER PAR 273A REPORTS R = 472 OHMS. = (-2.97V - -0.605V) / (0.00002A - 0.00503A) OCV - 3.04." PER ANALYSIS, THE PUMP CONTAINED BACLOFEN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS REPLACED. NO PT SYMPTOMS WERE REPORTED. NO ADD'L DETAILS WERE PROVIDED.
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 | 33 YR | EXPLANTED:| IMPLANTED:| CATHETER: MODEL 8709, LOT# L80506 |