FDA Adverse Event Injury Summary report: N

SYNCHROMED II

MDR report key: 4802989 · Received May 28, 2015

Report

Report Number: 3007566237-2015-01469
Event Type: Injury
Date Received: May 28, 2015
Date of Event: May 1, 2015
Report Date: May 7, 2015
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LKK
PMA / PMN Number: P860004
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE CATHETER. PRODUCT ID 8840, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

Description of Event or Problem · 1

ON (B)(6) 2015, THE PATIENT WAS BEING SEEN AT THE CLINIC AND WAS EXPERIENCING SUDDEN PSYCHOSIS. THE PSYCHOSIS BEGAN (B)(6) 2015. THE PATIENT WAS SCREAMING VERY LOUD THAT SHE "IS GOING TO DIE AND GOD IS BEAMING HER UP"; THE PATIENT WAS SCREAMING SO LOUD THAT PER THE REPORTER THEY WOULD NOT HEAR AN AUDIBLE PUMP ALARM. THE PATIENT WAS ALERT BUT AGITATED. THERE WAS NO INCREASED SPASTICITY OR FLACCIDNESS; THE PATIENT¿S SPASTICITY LEVEL WAS NORMAL. THE PATIENT HAD NO PRURITUS. THE EVENT LOGS WERE NORMAL. PUMP ERI (ELECTIVE REPLACEMENT INDICATOR) WAS 19 MONTHS. THE RESERVOIR VOLUME WAS 13 CC. THE PUMP DOSE WAS DECREASED BY 30% WHICH THE PHYSICIAN THOUGHT WAS SAFE FOR THE PATIENT AND THE PATIENT WOULD BE SENT TO THE HOSPITAL DUE TO THE PSYCHOSIS. THE DEVICE SYSTEM WAS DELIVERING GABLOFEN. THE OUTCOME WAS NOT REPORTED. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
347415	SYNCHROMED II	PUMP, INFUSION, IMPLANTED, PROGRAMMABLE	LKK	MEDTRONIC NEUROMODULATION	8637-40

Patients

Seq	Age	Sex	Outcome	Treatment
1	00027 YR		Required Intervention