FDA Adverse Event
Malfunction
Summary report: N
SYNCHROMED II
MDR report key: 2322603
·
Received October 13, 2011
Report
- Report Number
- 3007566237-2011-08867
- Event Type
- Malfunction
- Date Received
- October 13, 2011
- Date of Event
- September 8, 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
- OR, 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 = 447 OHMS. = (-2.67V - -0.426V) / (0.00002A - 0.00503A) OCV = 3.04".
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PUMP WAS REPLACED PROPHYLACTICALLY TO AVOID IN-VIVO BATTERY DEPLETION. THE PUMP WAS NEAR ERI. NO PT SYMPTOMS WERE REPORTED. THE PUMP WAS USED TO DELIVER LIORESAL. THE PT RECOVERED WITHOUT SEQUELA.
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 | 36 YR | CATHETER: MODEL 8709, LOT# J12213R01| IMPLANTED:| EXPLANTED: |