FDA Adverse Event Other Summary report: N

PRIMABELLA

MDR report key: 1822892 · Received August 27, 2010

Report

Report Number: 3006614152-2010-00001
Event Type: Other
Date Received: August 27, 2010
Date of Event: July 23, 2010
Report Date: August 27, 2010
Manufacturer: NEUROWAVE MEDICAL TECHNOLOGIES
Product Code: GZJ
PMA / PMN Number: K994387
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: IL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT OF THE DEVICE, WE WILL COMPLETE TESTING AND ANALYSIS TO DETERMINE IF PRODUCT MEETS ORIGINAL MANUFACTURING SPECIFICATIONS. WE WILL FILE A SUPPLEMENTAL MEDWATCH FORM.

Description of Event or Problem · 1

THE PATIENT IS A WOMAN WHO WAS (B)(6) PREGNANT AT THE TIME OF THIS EVENT. PATIENT'S PHYSICIAN PRESCRIBED PRIMABELLA FOR SEVERE NAUSEA SYMPTOMS ASSOCIATED WITH PREGNANCY ON (B)(6) 2010. PATIENT WORE DEVICE FOR 2 DAYS. PATIENT REPORTS THAT PRIMABELLA USE HELPED IN ALLEVIATION OF NAUSEA SYMPTOMS. THE PATIENT REMOVED THE DEVICE AT NIGHT ON BOTH DAYS AND SWITCHED TO ORAL ZOFRAN TO CONTROL NAUSEA WHILE SLEEPING. ON (B)(6) 2010, THE PATIENT WORE THE DEVICE AS USUAL WHEN SHE WOKE UP, BUT THE SYMPTOMS WERE MORE DIFFICULT TO TOLERATE. PATIENT PRESENTED TO EMERGENCY ROOM LATER IN THE DAY ON (B)(6) 2010. PATIENT CONTINUED TO WEAR THE DEVICE AFTER SHE ARRIVED AT THE EMERGENCY ROOM, DURING THE WAITING PERIOD, AND AFTER SHE WAS TAKEN TO A ROOM AND HOOKED UP TO AN IV. APPROXIMATELY ONE HOUR AFTER REMOVING THE DEVICE, AN ULTRASOUND REVEALED THAT SHE HAD A MISCARRIAGE. CAUSAL CONNECTION BETWEEN THE USE OF THE DEVICE AND THE MISCARRIAGE CANNOT BE RULED OUT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PRIMABELLA	GZJ NERVE STIMULATOR	GZJ	NEUROWAVE MEDICAL TECHNOLOGIES	WB-RL (ALA)	A0943A2

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other	PT TOOK ZOFRAN ON (B)(6) 2010 & (B)(6)10 AT NIGHT.\| 2010 AT NIGHT. SHE WAS ALSO HOOKED UP TO AN IV ON