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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

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MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR Back to Search Results
Model Number 7427
Device Problems Migration or Expulsion of Device (1395); Insufficient Information (3190)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2007
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 3487a-45, lot#: j0427847v, implanted: (b)(6) 2004, product type: lead. Product id: 3487a-45, lot#: j0417867v, implanted: (b)(6) 2004, product type: lead. Other relevant device(s) are: product id: 3487a-45, serial/lot #: (b)(4), ubd: 28-may-2008, udi#: (b)(4); product id: 3487a-45, serial/lot #: (b)(4), ubd: 19-mar-2008, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that sometime around 2007 their device rotated in their body, resulting in their device needing to be replaced. Pt mentioned it caused damage to their leads as well. Pt stated this was a result of weight loss.
 
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Brand NameSYNERGY
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
Manufacturer (Section D)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC MED REL MEDTRONIC PUERTO RICO
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key12367103
MDR Text Key268124002
Report Number3004209178-2021-12909
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation
Type of Report Initial
Report Date 08/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/14/2005
Device Model Number7427
Device Catalogue Number7427
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/14/2004
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: 08/25/2021 Patient Sequence Number: 1
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