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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7426
Event Type  Death  
Manufacturer Narrative

(b)(4).

 
Event Description

Additional information stated that "there was no mention of the medical device being the cause of death in the death report. " no further information was available regarding the cause of death.

 
Manufacturer Narrative

 
Event Description

It was reported that, following a device replacement, the patient experienced cognitive changes. It was stated the patient's device was put at lower settings than their previous device. The patient then had an unrelated surgery, and was in a rehab facility. After that, the patient was reprogrammed, and his settings were increased slightly. After this visit, the patient was "thrashing" at his wife and daily helper he has had for six years. The patient was also pulling at his catheter and feeding tube. The reporter stated "this is how he gets if he's too medicated," but the patient's medication had not changed in "years. " further information has been requested; a supplemental report will be submitted if additional information is received.

 
Manufacturer Narrative

Product id 7482a51, lot#, serial# (b)(4), implanted: 2012 (b)(6), explanted: product typ extension, product id 7438, lot#, serial# (b)(4), implanted: 2006 (b)(6), explanted: product typ programmer, patient product id 3387-40, lot# v000284, serial#, implanted: 2005 (b)(6), explanted: product typ lead. (b)(4).

 
Event Description

Additional information received reported that the patient had died. The reporter stated that the patient's death was 'indirectly' related to the stimulator. In (b)(6) 2012 the patient had an infection at the implantable neurostimulator (ins) site in the right chest area. It was stated that there was a 'little blue line that looked like a vein' on the patient's chest that appeared in early (b)(6). Then the line got 'much bigger. ' the patient was taken to the hospital and given intravenous (iv) antibiotics 'for a while,' then the doctor decided to remove the device due to infection by the end of (b)(6). When the battery was removed, 'it was such a shock to the patient's system that his mouth would not close,' and he could not eat. Nine days after surgery the patient was given a feeding tube. It was stated that the patient had pulled out his first two feeding tubes. The patient had difficulties with swallowing, and all of his food or drink was 'thickened. ' the third feeding tube was put in the patient's stomach. It was stated that a ct scan was performed in (b)(6). It was not clear if the scan showed anything. It was reported that around (b)(6) of 2012 ((b)(6) 2012) the patient had a brown-ish oozing fluid around his feeding tube. The home nurse was notified about the brown fluid, and stated that it was 'normal. ' on (b)(6) 2012 the patient had 'terrible stomach pain' and 'terrible leaking' at the site of the feeding tube. That patient was brought to the hospital on (b)(6) 2012. The doctors did discover a 'hole' in the patient's stomach. It was also noted that the week prior to going to the hospital the patient was in pain and he 'was not feeling good. ' there was an infection in the patient's stomach from the feeding tube. The patient died on (b)(6) 2012. No further information about the event was reported. Refer to manufacturer report #3004209178-2012-06182 for more information on the first infection and removal.

 
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Brand NameSOLETRA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
ceiba norte industrial park, r
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55431 554
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55431-5543
7635263987
MDR Report Key2671456
Report Number3004209178-2012-06129
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Other,Consumer
Reporter Occupation Other
Remedial Action Patient Monitoring
Type of Report Initial,Followup,Followup
Report Date 06/28/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received07/26/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date09/28/2012
Device MODEL Number7426
Device Catalogue Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received03/05/2013
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured03/28/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 07/26/2012 Patient Sequence Number: 1
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