Patient Letter Template - Important Medical Device Information printable pdf download

Patient Letter Template - Important Medical Device Information

Patient L etter T emplate -‐ f or u se b y P hysicians

Important M edical D evice I nformation

Medtronic I nSync® I II C ardiac R esynchronization T herapy P acemaker ( CRT-‐P)

Models 8 042, 8 042B, 8 042U

November 2 015

Dear P atient:

Medtronic r ecently n otified o ur o ffice a bout i mportant i nformation r elated t o y our

implantable I nSync® I II C RT-‐pacemaker. W e a re s ending t his l etter t o y ou i n a n e ffort t o k eep

you i nformed a bout t his c ommunication f rom M edtronic.

Medtronic h as d etermined t hat a v ery s mall n umber o f I nSync I II C RT-‐pacemakers, m ay

experience a n i ssue r elated t o b attery p erformance. M edtronic h as p rovided u s w ith

additional i nformation t hat e xplains t he i ssue i n m ore d etail. P lease c ontact o ur o ffice a t

<Insert c linic c ontact i

nformation> t o s peak w ith o ur s taff a bout a ny f urther a ctions t hat m ay

be r equired.

Symptoms o f l ightheadedness o r f ainting m ay b e a s ign t hat y our p acemaker i s n ot f unctioning

properly. I f y ou e xperience t hese o r a ny n ew o r u nexpected s ymptoms, s eek m edical

attention i mmediately; d o n ot w ait f or y our n ext a ppointment.

To l earn m ore a bout t his i ssue, y ou m ay a lso c ontact M edtronic P atient S ervices a t

(800) 5 51-‐5544, o ption 3 , e xtension 4 1835, o r v ia e mail a t

Medtronic P atient S ervices i s a vailable t o t ake y our c all M onday t hrough F riday f rom

8 a .m. t o 5 p .m. C entral T ime.

We s incerely a pologize f or a ny d ifficulties t his m ay c ause y ou a nd y our f amily.

Patient Letter Template - Important Medical Device Information