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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT MEDICAL PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG

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ABBOTT MEDICAL PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR; SCS IPG Back to Search Results
Model Number 3662
Device Problem Wireless Communication Problem (3283)
Patient Problem Failure of Implant (1924)
Event Date 05/26/2021
Event Type  Injury  
Manufacturer Narrative
Date of event is estimated.
 
Event Description
It was reported that the patient's ipg has consistent communication issues while trying to connect to external devices.A manufacturer representative met with the patient and attempted to connect multiple times, but the ipg would not hold a bond for long.As a result, surgical intervention may take place at a later date to address the issue.
 
Event Description
Additional information received stated that the patient underwent surgical intervention wherein the ipg was explanted and replaced.Post-operatively, stimulation therapy was restored and the communication issues were resolved.
 
Manufacturer Narrative
A4 patient weight added to the report.
 
Manufacturer Narrative
The reported observation ¿multiple error messages during cp/pc communication¿ was confirmed and duplicated during analysis.The root cause of the observation was due to the bluetooth (ble) antenna electrical contacts not being properly seated into the hybrid plug p2 of the printed circuit board.The ipg diagnostic logs from the field showed the bluetooth ¿ble¿ function did allow a communication session on the reported observation date.The ipg logs also showed the device had been programmed and stimulation was turned off and on.The device exhibited normal functionality during analysis when the device was in close proximity to an artemis programmer.As the distance between the returned ipg and artemis programmer increased, the ability to communicate was reduced, which is consistent with the field observation.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed with the tester bluetooth interface dongle positioned within 1ft of the returned ipg.Normal positioning of the bluetooth interface dongle is 6 ft from the ipg, but the returned ipg did not pass.Manufacturing investigation: plano site: no issue found with dhr review.There was no rework or ncmr associated with this event.
 
Manufacturer Narrative
The reported observation ¿multiple error messages during cp/pc communication¿ was confirmed and duplicated during analysis.The root cause of the observation was due to the bluetooth (ble) antenna leads were fractured at the header/can junction.The ipg diagnostic logs from the field showed the bluetooth ¿ble¿ function did allow a communication session on the reported observation date.The ipg logs also showed the device had been programmed and stimulation was turned off and on.The device exhibited normal functionality during analysis when the device was in close proximity to an artemis programmer.As the distance between the returned ipg and artemis programmer increased, the ability to communicate was reduced, which is consistent with the field observation.The device was subjected to a functional test on automated test equipment (ate).This tester verifies the electrical performance of the control/communication circuitry, and output signal integrity.All portions of ate testing passed with the tester bluetooth interface dongle positioned within 1ft of the returned ipg.Normal positioning of the bluetooth interface dongle is 6 ft from the ipg, but the returned ipg failed at this distance.Manufacturing investigation: plano site: no issue found with dhr review.There was no rework or ncmr associated with this event.
 
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Brand Name
PROCLAIM¿ 7 ELITE IMPLANTABLE PULSE GENERATOR
Type of Device
SCS IPG
Manufacturer (Section D)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer (Section G)
ABBOTT MEDICAL
6901 preston rd
plano TX 75024
Manufacturer Contact
heidi syndergaard
6901 preston road
plano, TX 75024
9723098000
MDR Report Key11979533
MDR Text Key255971438
Report Number1627487-2021-14766
Device Sequence Number1
Product Code LGW
UDI-Device Identifier05415067020222
UDI-Public05415067020222
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P010032
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup
Report Date 03/12/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date08/23/2020
Device Model Number3662
Device Catalogue Number3662
Device Lot Number6600086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/26/2021
Initial Date FDA Received06/10/2021
Supplement Dates Manufacturer Received06/24/2021
08/31/2021
02/19/2024
Supplement Dates FDA Received07/13/2021
09/09/2021
03/12/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/24/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient SexMale
Patient Weight100 KG
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