MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor,health profession report with the FDA on 2016-08-24 for SPF-XL IIB 2/DM IMPLANTABLE STIMULATOR N/A 10-1335M manufactured by Biomet Spine - Broomfield.
[52886364]
Without a product return, no product evaluation is able to be conducted. Current information is insufficient to permit a valid conclusion about the cause of this event. If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.
Patient Sequence No: 1, Text Type: N, H10
[52886365]
The sales associate reported that an implantable stimulator did not test. No further information at this time.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004485144-2016-00195 |
| MDR Report Key | 5900579 |
| Report Source | DISTRIBUTOR,HEALTH PROFESSION |
| Date Received | 2016-08-24 |
| Date of Report | 2016-07-27 |
| Date Mfgr Received | 2016-07-27 |
| Device Manufacturer Date | 2016-05-18 |
| Date Added to Maude | 2016-08-24 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MICHELLE COLE |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal | 80021 |
| Manufacturer Phone | 3034437500 |
| Manufacturer G1 | BIOMET SPINE - BROOMFIELD |
| Manufacturer Street | 310 INTERLOCKEN PARKWAY SUITE 120 |
| Manufacturer City | BROOMFIELD CO 80021 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80021 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | N/A |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPF-XL IIB 2/DM IMPLANTABLE STIMULATOR |
| Generic Name | IMPLANTABLE STIMULATOR |
| Product Code | LOE |
| Date Received | 2016-08-24 |
| Model Number | N/A |
| Catalog Number | 10-1335M |
| Lot Number | 576-16 |
| ID Number | N/A |
| Device Expiration Date | 2018-02-17 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BIOMET SPINE - BROOMFIELD |
| Manufacturer Address | 310 INTERLOCKEN PARKWAY SUITE 120 BROOMFIELD CO 80021 US 80021 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-24 |