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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

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MDT SOFAMOR DANEK PUERTO RICO MFG SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number 7426
Event Type  Death  
Event Description

The patient passed away one month ago due to complications from the dbs surgery. The first surgery on one side was done (b)(6) 2003 and he had a slight bleed. He went to therapy for speech and memory and was fine. His second surgery was (b)(6) 2003; 45 minutes before the surgery of 6 to 7 hours he had a massive hemorrhage. He was put on a feeding tube, bedridden, could not speak, sit or walk. He had to be flown home from the hospital. For almost 9 years, he was "locked in his body" and his wife cared for him. It was noted that the had no follow up doctor. Additional information has been requested.

 
Manufacturer Narrative

Extension: model 748251, serial# (b)(4), implanted: (b)(6) 2003, explanted:; lead: model 3387-40, lot# j0306915v, implanted: (b)(6) 2003, explanted:. (b)(4). Date of death: the exact date of the month was unknown, therefore the first of the month was chosen.

 
Manufacturer Narrative

(b)(4).

 
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Brand NameSOLETRA
Type of DeviceSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MEDTRONIC NEUROMODULATION
7000 central avenue ne rcw215
minneapolis MN 55431
Manufacturer Contact
diane wolf
7000 central avenue ne rcw215
minneapolis , MN 55431
7635263987
MDR Report Key2547617
Report Number6000032-2012-00037
Device Sequence Number1
Product CodeMHY
Report Source Manufacturer
Source Type Other
Reporter Occupation PATIENT FAMILY MEMBER OR FRIEND
Type of Report Initial,Followup
Report Date 03/28/2012
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/25/2012
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/28/2004
Device MODEL Number7426
Device Catalogue Number7426
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? No
Date Manufacturer Received07/19/2013
Was Device Evaluated By Manufacturer? No
Date Device Manufactured01/30/2003
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: 04/25/2012 Patient Sequence Number: 1
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