FDA Adverse Event
Death
Summary report: N
SYNCHROMED II
MDR report key: 2162131
·
Received July 11, 2011
Report
- Report Number
- 3007566237-2011-05323
- Event Type
- Death
- Date Received
- July 11, 2011
- Report Date
- June 20, 2011
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LKK
- PMA / PMN Number
- P860004
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS OF THE PUMP REPORTED HIGH S2 BATTERY RESISTANCE. THE BATTERY HAD HIGHER THAN EXPECTED RESISTANCE VALUES (WITH THE HIGHEST RESISTANCE OF 383 OHMS), WHICH EXCEEDED THE BATTERY SPEC REQUIREMENT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD HER LAST REFILL ON (B)(6) 2010 AND HER ALARM DATE WAS (B)(6) 2010. IT WAS STATED THAT SHE PASSED AWAY SOMETIME IN BETWEEN THOSE DATES BUT COULD NOT CONFIRM THE EXACT DATE. THE CAUSE OF THE DEATH WAS REPORTED AS "NOT RELATED TO THE PUMP". THE MEDICATION USED IN THE PUMP WAS DILAUDID 15MG/ML, CLONIDINE 600MG/ML, AND BUPIVACAINE 1/4%.
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 | Death | IMPLANTED:| CATHETER: MODEL 8709, LOT# N082887016| EXPLANTED: |