FDA Adverse Event Injury Summary report: N

ACTIVA

MDR report key: 2638509 · Received July 3, 2012

Report

Report Number: 3004209178-2012-05143
Event Type: Injury
Date Received: July 3, 2012
Report Date: June 5, 2012
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: MHY
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AK, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 37085-40 LOT# SERIAL# (B)(4) IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 37085-40 LOT# SERIAL# (B)(4) IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 37085 LOT# SERIAL# (B)(4) IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 3389S-40 LOT# V734509 SERIAL# IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3389S-40 LOT# V813627 SERIAL# IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYP LEAD. (B)(4).

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED FROM THE HCP REPORTED THAT THE HCP WAS UNAWARE OF ANY LOSS OF THERAPEUTIC EFFECT OR OTHER ISSUES. THE HCP REPORTED THAT THE PATIENT WAS SEEN ON (B)(6), 2012 AND WAS DOING WELL AT THAT TIME.

Description of Event or Problem · 1

IT WAS REPORTED THAT, AFTER THE PATIENT WAS IMPLANTED WITH THEIR DBS DEVICE, "WHEN THEY WOULD LIE DOWN TO GO TO SLEEP, THEY WOULD START ROLLING AND WRITHING IN BED." THE ROLLING/WRITHING WOULD STOP FOR TEN SECOND INTERVALS, THEN START UP AGAIN. THE PATIENT WOULD BE TIRED AFTER 9 HOURS OF SLEEP. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ACTIVA	STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR	MHY	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37601

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention