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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

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MDT SOFAMOR DANEK PUERTO RICO MFG SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 7427
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Wound Dehiscence (1154); Abscess (1690); Purulent Discharge (1812); Foreign Body Reaction (1868); Pain (1994); Irritability (2421)
Event Date 01/01/2003
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: 7495-25, lot/serial#: (b)(4), implanted: (b)(6) 2002, product type: extension. Product id: 7495lz25, lot/serial#: (b)(4), implanted: (b)(6) 2002, product type: extension. Product id: 3487a, lot/serial#: (b)(4), product type: lead. Product id: 3487a, lot#serial#: (b)(4), product type: lead. Analysis results were not available at the time of this report. A follow up report will be sent once analysis is complete. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome. The patient reported that her body rejected the device. The patient had a bad abscess. The patient reported that the device was implanted in her cheek of buttocks. The patient reported that it was irritated where it was because it kept getting hit. The patient reported that she used lidocaine but she couldn't bear the pain anymore. The patient reported that the ins was removed because the skin busted open and it was draining puss. No further complications were reported.
 
Manufacturer Narrative
Analysis of the ins (b)(4) found no significant anomalies. Product analysis #(b)(4). The implantable neurostimulator (ins) passed functional testing. Analysis determined there were no issues when pressing on the ins can. Analysis determined the telemetry was acceptable. The ins output was tested through the returned extension and lead. Good stable output was observed on all electrode pairs the ins had when it was received. The ins output was tested through the returned extension and lead. Good stable output was observed on all electrode pairs. The ins output was tested through the returned extension and cut lead. Good stable output was observed on all electrode pairs the ins had when it was received. The ins output was tested through the returned extension and cut lead. Good stable output was observed on all electrode pairs. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Continuation: product id 7495-25 (b)(4) implanted: (b)(6)2002 product type extension product id 7495lz25 (b)(4) implanted: (b)(6)2002 product type extension product id 3487a lot# j0211651v product type lead product id 3487a lot# j0211651v product type lead all previously reported codes are still applicable.
 
Event Description
Information was received from a patient who was implanted with an implantable neurostimulator (ins) for failed back surgery syndrome. The patient reported that her body rejected the device. The patient had a bad abscess. The patient reported that the device was implanted in her cheek of buttocks. The patient reported that it was irritated where it was because it kept getting hit. The patient reported that she used lidocaine but she couldn¿t bear the pain anymore. The patient reported that the ins was removed because the skin busted open and it was draining puss. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer. The patient stated that the reason their device abscessed was likely not due to the device, but rather the device location. The device was implanted in their butt, so whenever they sat, moved, bumped it the device was irritated. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameSYNERGY
Type of DeviceSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Manufacturer (Section D)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer (Section G)
MDT SOFAMOR DANEK PUERTO RICO MFG
barrio marianna rd 909, km0.4
humacao PR 00792
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7802608
MDR Text Key117791893
Report Number1030489-2018-01156
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,Followup,Followup,Followup,Followup
Report Date 11/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date08/28/2003
Device Model Number7427
Device Catalogue Number7427
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/24/2012
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/06/2018
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/07/2002
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: 08/21/2018 Patient Sequence Number: 1
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