MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2009-07-23 for PUMP MMT-515NAP PRDGM INS V2.1 PLEN manufactured by Medtronic Puerto Rico Operations Med-rel.
[14870929]
The customer's mother stated that the insulin pump alarmed during the manual prime. The customer's mother also reported that the customer was being treated with multiple daily injection therapy by her doctor. Nothing further was reported.
Patient Sequence No: 1, Text Type: D, B5
[15451744]
Currently, it is unknown whether or not the device may have caused or contributed to the event. The device has been returned, but not yet evaluated. No conclusion can be drawn at this time. Further information will follow once the analysis has been completed.
Patient Sequence No: 1, Text Type: N, H10
[27865250]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
[27865251]
It was further reported that a malfunction occurred. The battery was stated to be not charging right. This started a month after implant.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2009-07381 |
| MDR Report Key | 1421761 |
| Report Source | 00 |
| Date Received | 2009-07-23 |
| Date of Report | 2009-07-06 |
| Date of Event | 2009-07-06 |
| Date Mfgr Received | 2014-05-20 |
| Date Added to Maude | 2009-07-30 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | DIANE WOLF |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 |
| Manufacturer City | NORTHRIDGE CA 913251219 |
| Manufacturer Country | US |
| Manufacturer Postal | 9132512195 |
| Manufacturer Phone | 7635263987 |
| Manufacturer G1 | MEDTRONIC PUERTO RICO OPERATIONS MED-REL |
| Manufacturer Street | 7000 CENTRAL AVENUE NE RCW215 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777407 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 4070 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUMP MMT-515NAP PRDGM INS V2.1 PLEN |
| Generic Name | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF |
| Product Code | LGT |
| Date Received | 2009-07-23 |
| Returned To Mfg | 2009-07-15 |
| Model Number | MMT-515NAP |
| Catalog Number | MMT-515NAP |
| Operator | LAY USER/PATIENT |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS MED-REL |
| Manufacturer Address | CALL BOX 4070 RD 31 KM 24 HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777407 US 00777 4070 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2009-07-23 |