FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 2000273
·
Received February 17, 2011
Report
- Report Number
- 9614453-2011-01176
- Event Type
- Injury
- Date Received
- February 17, 2011
- Date of Event
- January 24, 2011
- Report Date
- January 27, 2011
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE PATIENT NOTICED A RETURN OF HER TREMORS AND WHEN THE DEVICE WAS CHECKED NO TELEMETRY COULD BE TAKEN. THE IPG WAS REPLACED TWO YEARS AFTER IMPLANT. HCP SUSPECTED EARLY BATTERY DEPLETION. LEADS AND EXTENSIONS WERE NOT REPLACED. OUTPUT SETTINGS BEFORE EXPLANT: 2.9V, 90PW, 135HZM 1 (-), 2(-), 3(+). OUTPUT SETTINGS AFTER REPLACEMENT: 1.6VM 90PW, 135HX, 2(-), CAN TELEMETRY WAS TAKEN AFTER REPLACEMENT, IT SHOWED 0&2: OVER 2000 OHMS, 1&3: BELOW 50 OHMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MEDTRONIC EUROPE SARL | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention | EXTENSION: MODEL 7482, LOT# NHU190257V| EXTENSION: MODEL 7482A51, LOT# NHU196694V| LEAD: MODEL 3387, LOT# V208201| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# V204738| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED: |