N
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
MAUDE MDR 8624871
- MDR report key
- 8624871
- Report number
- 2182208-2019-00933
- Event key
- 0
- Event type
- 3
- Date of event
- 2019-05-10
- Date received
- 2019-05-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- PAULA BIXBY
- Address
- 8200 CORAL SEA ST NE MOUNDS VIEW MN 55112 US
- Phone
- 763-763-7635
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PATIENT CABLE | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) | MEDTRONIC, INC. | DSA | 5487 | 5487 | 686940001 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2019-05-20 | 5076 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE CABLES WOULD NOT CAPTURE WHEN CONNECTED TO THE LEADS AND TO AN EXTERNAL PULSE GENERATOR (EPG). THE PHYSICIAN THEN OPTED TO CONNECT THE LEADS TO AN IMPLANTABLE PULSE GENERATOR (IPG) THAT WAS TAPED EXTERNALLY TO THE PATIENT'S NECK UNTIL A DEVICE COULD BE IMPLANTED. THE CABLES ARE EXPECTED TO BE RETURNED FOR SERVICE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.