MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04 report with the FDA on 2012-07-02 for SELECT 1.5 199584-001 manufactured by Empi, Inc..
[10138055]
Device, leadwire, and electrodes were investigated. Device and electrodes met specifications, the leadwire device connection was intermittent. An intermittent leadwire could have caused a sensation of surging current: the device is designed to ramp down to a safe level when the connection between the device and the electrode is open, and to ramp back up to the previously set level when the connection is restored. This should not have caused any physical harm to the patient because the energy delivered would not exceed the previously set level, but the ramping up sensation could be startling.
Patient Sequence No: 1, Text Type: N, H10
[20089409]
It was reported that a patient was shocked while wearing the select 1. 5 device. The patient is (b)(6) and uses the device 24/7. She was wearing the device in school and experienced a sharp shock down both legs to her knees. She was then taken to the emergency room where the dr placed her in the hospital. The patient was using the program hip/back intensity 40. 0. Only one leadwire was used, and the electrodes were placed on each side of her spine on her lower back hip area. She has no metal in her body and never had surgery on her back; she used the device for pain management. The patient was released from the hospital and has been in a wheelchair more than out, she is very weak in both legs and is still having pain. The patient indicated that she will not use the unit any longer.
Patient Sequence No: 1, Text Type: D, B5
[20278084]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1721293-2012-00003 |
| MDR Report Key | 2636089 |
| Report Source | 04 |
| Date Received | 2012-07-02 |
| Date of Report | 2012-06-01 |
| Date of Event | 2012-06-01 |
| Date Mfgr Received | 2012-06-01 |
| Device Manufacturer Date | 2010-05-27 |
| Date Added to Maude | 2012-07-05 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | PATIENT |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MS DEBBIE MIRANDA |
| Manufacturer Street | 205 HWY 22 EAST |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal | 57226 |
| Manufacturer Phone | 6058477057 |
| Manufacturer G1 | EMPI, INC. |
| Manufacturer Street | 205 HWY 22 EAST |
| Manufacturer City | CLEAR LAKE SD 57226 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57226 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SELECT 1.5 |
| Generic Name | SELECT 1.5 |
| Product Code | NYN |
| Date Received | 2012-07-02 |
| Returned To Mfg | 2012-07-24 |
| Model Number | 199584-001 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EMPI, INC. |
| Manufacturer Address | 205 HWY 22 EAST CLEAR LAKE SD 57226 US 57226 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other | 2012-07-02 |