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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 Degraded (1153); Device Contamination with Chemical or Other Material (2944); Insufficient Information (3190)
Patient Problems Bruise/Contusion (1754); Hematoma (1884); Hemorrhage/Bleeding (1888); Myocardial Infarction (1969); Therapeutic Response, Decreased (2271); Caustic/Chemical Burns (2549); Insufficient Information (4580)
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a healthcare professional (hcp) regarding a patient who was implanted with a neurostimulator for complex regular pain syndrome type i. It was reported that the implanted neurostimulator (ins) was removed and the hcp reported there was a white substance on the ins and in the pocket, which caused a hematoma. The hcp removed the ins and the white substance from the pocket. Lab results showed the substance contained calcium, phosphorus, oxygen, and lithium. The patient was going to be tested for heavy metal. An additional report stated that the battery of the device had ruptured and the patient experienced a persistent hematoma due to the lithium. The hcp was looking for information on how to manage the bleeding/hematoma in the patient. It was also noted that the patient hadn't turned on the device for about six years. No further complications were reported or anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) via a manufacturer representative (rep). It was reported that the hcp thought the battery leaked, but didn¿t determine a cause and it wasn¿t sure that this was accurate. It was noted that the lab couldn¿t identify the amounts of each substance. It was also noted that the patient got the hematoma right after the surgery.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was reported that the rep spoke with the patient's doctor's office. There is no formal report. The lab just called the doctor to give them the results. The ins wasn't sent out to a lab, but was done at an orthopedic research lab at the hospital. No further information was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from the patient indicated that they were bruised bad from the physician having to get all of the ¿battery acid¿ out of them. No further complications were reported or anticipated.
 
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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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key9250379
MDR Text Key164406959
Report Number3004209178-2019-20621
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 company representative,consum
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2005
Device Model Number7427
Device Catalogue Number7427
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/07/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/05/2004
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: 10/29/2019 Patient Sequence Number: 1
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