FDA Adverse Event
Injury
Summary report: N
SOLETRA
MDR report key: 1910728
·
Received November 22, 2010
Report
- Report Number
- 3004209178-2010-09862
- Event Type
- Injury
- Date Received
- November 22, 2010
- Date of Event
- October 4, 2010
- Report Date
- November 15, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- 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 INFO REPORTING A PT WHO HAD A LEAD REVISION BECAUSE THE LEAD PULLED OUT 9 MM. THE LEAD WAS SECURED WITH A STIMLOC WHEN IT WAS IMPLANTED ON (B)(6) 2010 AND POST-OPERATIVE MRI OF THE BRAIN SHOW LEADS IN PLACE. POST OPERATIVE SKULL X-RAY ON (B)(6) 2010 SHOWS MIGRATION OF THE LEFT LEAD. LEAD WAS REPOSITIONED ON (B)(6) 2010. PT OUTCOME IS REPORTED AS DOING WELL AND RECEIVING GOOD STIMULATION. REFERENCE MFR REPORT # 3004209178-2010-09864.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 7438, LOT #: NHL028577P| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3389S-40, LOT #: V514982| LEAD: MODEL 3389S-40, LOT #: V514982| EXPLANTED:| STIM ACCESSORY: MODEL STIMLOC, LOT #: 082230609A| EXTENSION: MODEL 7482A51, LOT #: NHU219942V| MODEL 7426, LOT #: NFW162195H| IMPLANTABLE NEURO STIMULATOR| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482A51, LOT #: NHU219940V| EXPLANTED:| EXPLANTED: |