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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE Back to Search Results
Model Number 3058
Event Date 06/07/2013
Event Type  Death  
Event Description

It was reported the patient died on (b)(6) 2013 due to ¿acid leakage and parkinson¿s. ¿ it was stated the patient had parkinson¿s stage three and they fell down the stairs while walking their dog and the patient went to a rehab facility after the fall. The patient did not do her leg exercises at the rehab facility, so her legs ¿atrophied¿ and she could not get out of bed. By lying in bed she became stiff from parkinson¿s and lost weight from not eating and having a poor appetite. It was stated the battery packs that were in her, ¿the acid started leaking and created holes in her kidneys. ¿ when the patient fell in 2013, she weighed (b)(6) pounds and at her death in (b)(6) 2013, she weighed (b)(6) pounds. The caller wanted to donate the programmer.

 
Manufacturer Narrative

Product id: 3037, serial# (b)(4), product type: programmer. Patient product id: 3 093-28, lot# v800436, implanted: (b)(6) 2011, product type: lead. (b)(4).

 
Event Description

Additional information received reported that per the coroner¿s office the primary cause of death was parkinson¿s disease. It was noted that no autopsy was performed. It was later reported that a healthcare provider verified that the primary cause of death was parkinson¿s disease. The healthcare provider reported that the acid that was mentioned was ¿not from the battery of any device. ¿ it was noted that the patient had poor circulation because they were not eating, drinking, or moving and that was causing fluid build-up issues. The healthcare provider stated that this had ¿nothing to do with the device at all. ¿.

 
Manufacturer Narrative

Additional information indicated that the patient¿s symptoms, reported device issues, and death were not related to the device. (b)(4).

 
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Brand NameINTERSTIM II
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
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 55432
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55432
7635263987
MDR Report Key3486291
Report Number3004209178-2013-21348
Device Sequence Number1
Product CodeEZW
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 10/31/2013
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/25/2013
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device EXPIRATION Date03/28/2013
Device MODEL Number3058
Device Catalogue Number3058
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received02/04/2014
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured10/03/2011
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: 11/25/2013 Patient Sequence Number: 1
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